Professional Documents
Culture Documents
DISTRICT COURT FOURTH JUDICIAL DISTRICT Medical Malpractice/Wrongful Death Court File No. 27-CV-07-1679 Judge John L. Holahan
Mary Weiss, on her own behalf, and as next of kin and Trustee of the estate of Dan Markingson, deceased, Plaintiff,
VS.
Board of Regents For the University of Minnesota; Dr. Stephen Olson; Dr. Charles Schultz; Institutional Review Board for the University of Minnesota; Astrazeneca Pharmaceuticals LP; Astrazeneca LP; and Zeneca, Inc., Defendants.
DEFENDANTS DR. STEPHEN OLSON'S AND DR. CHARLES SCHULZ'S AND THE UNIVERSITY OF MINNESOTA PHYSICIANS' DISCLOSURE OF FINDINGS AND OPINIONS OF EXPERT WITNESS DAVID DUNNER, M.D.
It is expected that David Dunner, M.D., a medical doctor and psychiatrist duly licensed to practice medicine in the State of Washington, will be called to testify as an expert witness at the time of trial. A copy of his Curriculum Vitae is attached as Exhibit "A" which sets forth information pertaining to his background, education, training, hospital appointments, board certification, licensure, professional affiliations, honors/awards, publications and presentations. Dr. Dunner has reviewed the following documents and case-related materials: 1. Copies of the medical charts and records of Dan Markingson, also known as Daniel Weiss, deceased, from the following healthcare providers: a. b. c. d. e. f. g. h.
1.
Fairview University Medical Center; Minnesota Regional Coroner's Office; Regions Hospital; Theodore I Residence/Boston Health Care Systems; Dr. Victor Amira; Children's Health of St. Paul; Group Health/HealthPartners; Dr. Joseph Gryskiewicz; University Health Service, Ann Arbor;
j. k. 1. m. 2.
University of Minnesota, Department of Psychiatry; Dakota County; Eagan Counseling Clinic; Pharmerica;
In addition to medical records, Dr. Dunner has reviewed the following materials and information regarding this matter: n. o. P. q. r. s. t. u. v. w. Deposition transcript of Dr. Olson; Deposition transcript of Dr. Schulz; Deposition transcript of Mary Weiss; Deposition transcript of Mike Howard; Deposition transcript of Dr. Arlow Andersen; Deposition transcript of David Pettit; Deposition transcript of Stacy Hohler; Deposition transcript of April Arnold; Deposition transcript of Daniel Buse; Expert Disclosures of James I. Hudson, M.D. and Harrison G. Pope, M.D., Keith A. Horton, M.D., Paul Root Wolpe, Ph.D., and Donald L. Frankenfeld, Economist. E-mails written by Dan Markingson to his mother, Mary Weiss; Investigative report of the Office of the Ombudsman; and Report of Department of Health & Human Services. July 22, 2005 Establishment and Inspection Report by the FDA written by Sharon L. Matson, Investigator. Informed Consent Document. Pre-petition Screening Team Recommendations dated November 14, 2003. Order to Confine, to Transport for Examination, Hearing, Appointment of Attorney, Examiner and Notice by Judge Edward Lynch dated November 17, 2003. Adult Consent Form for CAF Study Participation signed on November 21, 2003. Findings of Fact, Conclusions of Law, and Order for Stay of Commitment by Judge Robert F. Carolan dated November 20, 2003. Various correspondences written by Mary Weiss. Letters written back to Mary Weiss from a variety of individuals. Journals kept by Mr. Markingson. The American Journal of Psychiatry July 2007, published results on the Caf Study.
Dr. Dunner is expected to testify at trial on issues of the standard of care, causation, damages, and the nature, extent and duration of Dan Markingson's medical condition. He will also respond to any and all findings and opinions expressed by each and every one of the Plaintiff's medical experts.
Dr. Dunner's testimony will be based upon his education, training and experience, as well as his understanding of the medical teachings and practices which pertain to the issues presented in this case. In formulating his fmdings and opinions, he has reviewed and taken into consideration Mr. Markingson's medical records, information and additional discovery materials provided to him for his review as listed above. All of Dr. Dunner's opinions will be stated to a reasonable degree of medical and psychiatric certainty, unless otherwise specified. Dr. Dunner is expected to testify that that Dr. Stephen Olson and Dr. Charles Schulz both provided reasonable and appropriate care and treatment to Mr. Markingson. He will opine that each one of them satisfied the standard of care applied to them as physicians in their individual roles, as study investigators, and in the case of Dr. Schulz, as the head of the Department of Psychiatry at the University of Minnesota. Dr. Dunner will testify that Mr. Markingson's participation in the CAFE Study in conjunction with all of the additional care and treatment he was receiving through Theodore I House, adult group therapy at the Fairview Day Treatment Center, individual therapy with Dr. Arlow Andersen, and monitoring by David Pettit of Dakota County was reasonable and appropriate care and treatment for Mr. Markingson. Dr. Dunner is also expected to testify that the care and treatment rendered to Mr. Markingson by Dr. Olson and Dr. Schulz did not cause or contribute to Mr. Markingson's suicide and ultimate death.
Factual Background
Daniel Weiss was born on November 25, 1976. He was the only son of Mary Weiss and Tom Rosner, who never married. Ms. Weiss raised her son as a single parent. Mr. Markingson did not have a relationship with his biological father. It does not appear that Mr. Markingson had a strong male influence in his life during his formative years. Beginning in approximately 1983, Mr. Markingson was seen repeatedly throughout his childhood for complaints of headaches. His medical records reflect the fact that the source of his headaches may have been stress-related. On October 3, 1984, counseling was recommended to Ms. Weiss for her son's ongoing headache complaints. The same recommendation again occurred on January 29, 1985. It does not appear that Mr. Markingson received the counseling that was recommended. From April 1986 through 1992, Ms. Weiss had her son seen many times for headache complaints. He received neurology, relaxation therapy, chiropractic care, saw an ophthalmologist and also saw allergists to determine the source of the headaches. A neurologist suggested to Ms. Weiss that the source of the headaches were muscle contraction, i.e., stress. In August 1989, Mr. Markingson was placed on amitriptyline, brand name Elavil. Elavil is often prescribed for the relief of symptoms of mental depression. It is a member of the group of drugs called tricyclic antidepressants. It is unclear, based on the records, why Mr. Markingson was placed on this medication. It appears that Mr. Markingson may have remained on Elavil throughout his high school years. Mr. Markingson completed his high school education and then took one year off to write a book and/or screenplay. Thereafter, he attended Hamline University for his freshman and
sophomore years. He transferred to the University of Michigan where he completed his studies in 2000, and received a B.A. in English. In the late summer or early fall of 2000, Mr. Markingson moved to Los Angeles, California. The records reflect that Mr. Markingson's intended career path was to become an actor and/or writer. When he first arrived in Los Angeles, he worked a series of odd jobs, which included selling papers for the L.A. Times and doing office work in an accountant's office. The only steady job he held was at Star Line Tours as a tour guide. He was employed there from February 15, 2002 through August 2003. Initially, he worked full time at Star Line Tours, but changed his status to part time in early 2003. It is believed Mr. Markingson unexpectedly resigned from that position in August 2003. Ms. Weiss visited her son shortly after he moved to California in 2000. However, according to Ms. Weiss, their relationship completely changed after that visit. Ms. Weiss described the fact that her relationship with Mr. Markingson "totally deteriorated." He stopped calling her and he stopped writing to her. She described the fact that after that visit, communication between herself and her son completely ended. During Mr. Markingson's residency in California, he changed his last name from Weiss to Markingson. It is unknown why Mr. Markingson chose to change his last name. Ms. Weiss went to California in August 2003 to attempt to reconnect with her son. When she went out to Los Angeles, she had difficulty finding him and had to contact his employer to discern his whereabouts. Ultimately, Ms. Weiss was able to find her son and, after some time, convince him to return to Minnesota. Ms. Weiss testified that upon seeing her son during this initial visit to Los Angeles, she believed that he was mentally ill. He made comments about the fact that there would be an event that was going to occur, that people were watching him, and that there were aliens present in his home. He also commented that he may be called upon to harm people prior to his return to Minnesota Upon his return to Minnesota, Ms. Weiss arranged for her son to be seen at Group Health/HealthPartners. This visit occurred on September 4, 2003. Prior to the visit, Ms. Weiss had called the office to report that her son had been experiencing memory loss and weight loss. A physical examination was conducted which appeared to be normal. Mr. Markingson also underwent laboratory tests. Those results showed a slightly underactive thyroid. Mr. Markingson's mental health was not specifically addressed at that visit. Mr. Markingson did not see a psychiatrist, psychologist, therapist, or any other mental healthcare provider at that time. The records reflect that on or about September 9, 2003, Mr. Markingson returned to California. After his return to California, Mr. Markingson began exchanging e-mails with "Guardian Angel Daisy@ hotmail.com " and "Michael the Archangell@hotmail.com ." These emails were exchanged from September 19 through September 23, 2003. Ms. Weiss assumed the identity of "Guardian Angel Daisy" and "Michael the Archangel" and exchanged these e-mails with Mr. Markingson. It is unknown whether or not Mr. Markingson knew that his mother was the author of these e-mails. In the context of these e-mails, Mr. Markingson discussed an event that was purportedly going to occur in Duluth where he may be called upon to kill certain
individuals. It was the promise of this "big event" that prompted Mr. Markingson to return to Minnesota. Mr. Markingson returned to Minnesota and moved into his mother's home, where she resided with a male companion. Purportedly, Mr. Markingson spent the majority of his days alone in his childhood room. According to his mother and her companion, he continued to exhibit what they believed to be delusional and paranoid behavior. He would repeatedly make reference to the "big event," "being the chosen one," and his belief that there were references being made about him on television. From the time of Mr. Markingson's return to Minnesota in late September 2003, up until November 12, 2003, he did not see a psychologist, psychiatrist, therapist, or a physician for his mental health condition. Purportedly, on November 12, 2003, Mr. Markingson told Ms. Weiss' companion, Michael Howard, that he intended to slit his mother's throat. This threat prompted Ms. Weiss and Mr. Howard to contact the police via 911. Mr. Markingson was transported in handcuffs from Ms. Weiss's home to Regions Hospital. The police report indicates that Mr. Markingson was aggressive verbally at his mother's home and indicated that he was unwilling to go to the hospital. However, Mr. Markingson calmed down prior to his arrival at Regions Hospital.
Hospitalization
Mr. Markingson was originally transported to Regions Hospital emergently. A history was taken from his mother by a social worker about Mr. Markingson's current mental health condition and history. She reported that Mr. Markingson had been discussing a "big event" that was satanic in nature. She reported that he had made threats to cause her harm on the day of his transport to the hospital. Mr. Markingson originally denied making these threats, but later acknowledged that he may be contacted in the future to do so as a result of the upcoming "big event." He stated that he would decide whether or not to follow through. He also denied any suicidal ideation or thoughts of harming others. The initial intake at Regions Hospital was done by Dr. Darren Manthey and Dr. Bradley Hernandez. They determined that Mr. Markingson was paranoid, delusional, grandiose and threatening to harm others. Due to a space issue and a stated family preference, Mr. Markingson was transferred to Fairview University Medical Center ("FUMC"). Mr. Markingson was admitted to FUMC on a 72-hour hold by resident, Dr. John Darling. Prior to his admission to the psychiatric ward at FUMC, Drs. Darling and Olson took a history and performed an examination of IVIr. Markingson. Dr. Olson verified Dr. Darling's findings and signed off on them as the attending psychiatrist. Drs. Darling and Olson found that the patient's eye contact was good, but intense at times. His mood was noted to be "good," and his affect was bright, and at times expansive. Drs. Darling and Olson found that his thought process was coherent and linear. Drs. Darling and Olson also found that the patient's thought content was positive for delusions, paranoia and ideas of reference. Mr. Markingson's insight and judgment were noted to be impaired by his significant delusional framework. Drs. Darling's and Olson's initial impression was that Mr. Markingson had a recent onset of multiple delusions and psychotic symptoms that had been developing in recent months. Drs. Darling's and Olson's
diagnosis was psychosis and mood disorder, to rule out bipolar affective disorder, psychosis and schizophrenia. On November 13, 2003, Dr. Olson wrote his admission note for Mr. Markingson. The basis of the information contained in that note came from both Mr. Markingson himself, as well as his mother. Mr. Markingson acknowledged at that time that he did have some unusual beliefs, but attributed them to a lack of sleep and anxiety. Ms. Weiss advised Dr. Olson that she had had very little contact with her son over the last year and a half. Ms. Weiss also informed Dr. Olson she recently exchanged e-mails with her son using false identities. Dr. Olson's notes reflect that Mr. Markingson appeared to be downplaying his psychosis and trying to present himself in the best possible light. Dr. Olson's diagnosis for Axis I. was Psychosis NOS, and a differential diagnosis to include paranoid schizophrenia, schizoaffective disorder, and bipolar disorder with manic psychosis. Dr. Olson noted that the patient had an extended period of deterioration and elaborate, disorganized and fragmentary delusional thinking suggestive of paranoid schizophrenia. However, Dr. Olson could not rule out bipolar disorder given the patient's claim of a sleep disorder and increased level of self-esteem. The 72-hour hold was to remain in place and Dr. Olson prescribed Risperdal for the patient. Mr. Markingson initially refused to take Risperdal. On November 14, 2003, Mr. Markingson met with the pre-petition screening team. At that point in time, it was noted that the patient did not have the capacity to make decisions regarding neuroleptic medication, and a Jarvis petition was being considered. During the interview, Mr. Markingson advised the screening team that he would be willing to be a voluntary patient and follow his physician's recommendations, but that he did not want to take any neuroleptic medication. Dr. Olson also spoke to the pre-petition screening team, and advised them that the patient had bizarre beliefs and lacked insight into the cause of those beliefs. There was also concern about whether the patient would follow through without patient care or whether an admission to an inpatient facility would be necessary. Commitment was ultimately recommended by the screening team and Dr. Olson. In conjunction with the recommendation of the screening team for commitment, Dr. Olson wrote an examiner's statement in support of the petition for commitment. This was written on November 14, 2003. Dr. Olson described the history of the bizarre thinking of the patient and his threats to harm his mother. Dr. Olson advised the court that the development of the delusional thinking appeared to have occurred in the last 6-18 months and that the patient lacked a prior history of psychosis. He also reported to the court that the patient lacked insight into the causation of his delusional thinking. Dr. Olson advised the court that his diagnostic impressions and conclusions were that the patient had psychosis NOS; paranoid schizophrenia versus psychiatric mania versus psychosis due to a medical condition. In Dr. Olson's opinion at that time, Mr. Markingson was at high risk for acting on his delusions. This was submitted to the court, along with the pre-petition screening team's recommendation for commitment. According to a progress note written by Dr. Olson at 5:00 p.m. on November 14, he met with Mr. Markingson and filled out the examiner's statement in support of the petition for commitment. This note reflects that on the evening of November 13, 2003, Mr. Markingson agreed to take the prescribed anti-psychotic medication Risperdal. Thus, his medication use
started at that time. Also, during Dr. Olson's meeting with Mr. Markingson, he admitted that his unusual beliefs had gone on longer than he had originally acknowledged, but would not reveal for how long. He also continued to deny some of the history that had been reported by his mother. However, he did admit that he had been concerned about a satanic cult, his mother's identity, being "the one," and having Angelina Jolie as his sister. Overall, Dr. Olson noted that the patient appeared to be minimizing his past thoughts, and that his insight and judgment were impaired. Dr. Olson questioned whether or not Mr. Markingson was sincere about voluntarily agreeing to seek treatment. Thus, he was of the opinion that going forward with the commitment would be appropriate and that a Jarvis hearing may be necessary if the patient did not continue to be medication compliant. On November 17, 2003, a Dakota County District Court Judge set forth an Order to Confine, to Transport for Examination, Hearing, Appointment of Attorney, Examiner and Notice. The petition was brought by Kathryn Knight for judicial commitment of Daniel Markingson as a mentally ill person. The judge ordered that FUMC was to retain custody of Mr. Markingson for observation, evaluation, diagnosis and emergency treatment. A Jarvis petition was not sought because Mr. Markingson had remained compliant and was taking his Risperdal as prescribed. After taking the medication for several days, Mr. Markingson's case manager and therapist, Kathleen Bernhaft, wrote the treating physician's recommendations to the court. The recommendation of FUMC and Dr. Olson was that a stay of commitment would be appropriate, the reason being that Mr. Markingson had been cooperative with his inpatient treatment and was in the process of developing an aftercare plan. Further, Mr. Markingson had been medication compliant. The diagnosis at that time was psychosis NOS, mood disorder NOS, rule out bipolar affective disorder with psychosis and schizophrenia. Erin Holker, Ph.D. LP at FUMC performed a neuropsychological evaluation of Mr. Markingson on November 18, 2003. Testing was done to determine Mr. Markingson's intellectual functioning level and his cognitive impairment, if any. The testing revealed that Mr. Markingson's overall intellectual functioning was in the superior range. Moreover, no cognitive difficulties were noted which could potentially interfere with Mr. Markingson's ability to actively participate in his own care and treatment. Mr. Markingson told Dr. Holker of his desire to continue the use of Risperdal and that he was committed to participating in his care and treatment. On November 19, 2003, Dr. Olson discussed the CAF Study with Mr. Markingson and his mother. According to his November 19 note, both Mr. Markingson and his mother were interested in the Study. Dr. Olson provided them both with materials for their review and consideration. Assessment of informed consent was not limited to this single session. This was an ongoing process during Mr. Markingson's hospitalization. Dr. Olson continued to assess his ability to understand the information presented to him. Dr. Olson also continued to present information to Mr. Markingson about alternative care options. Dr. James Jacobson conducted an examination of Mr. Markingson on November 19, 2003, pursuant to the court's order. Dr. Jacobson's diagnosis for Axis I of Markingson was
psychosis, NOS, rule out mood disorder, NOS, rule out bipolar disorder with psychosis versus rule out schizophrenia. Dr. Jacobson took a history and performed an exam on Mr. Markingson. Dr. Jacobson found that Mr. Markingson was fully oriented and that his thinking was logical and goal directed. He did not appear to be delusional, but did admit having peculiar thoughts in the past. He expressed to Dr. Jacobson his consent to the stay of commitment. Dr. Jacobson's recommendation to the court was that Mr. Markingson remain hospitalized for continued evaluation to ensure that his recent mental health improvements continued. He also recommended that a commitment or a stay of commitment would be appropriate for Mr. Markingson. A Jarvis hearing was not recommended by Dr. Jacobson because Mr. Markingson was compliant with his medication and he agreed to continue to take his medication. On November 20, 2003, Mr. Markingson appeared in court. During this proceeding, he was represented by an attorney. At that time, Mr. Markingson indicated that he voluntarily was agreeing to a stay of commitment. He admitted to being mentally ill and in need of treatment. The commitment was to be stayed for six months with a list of terms that included: "(a) that the respondent remain hospitalized, cooperative with the treatment plan at Fairview University Medical Center until medically discharged, and follow all of the aftercare recommendations of the treatment team; (b) that the respondent enter, participate in and satisfactorily complete the inpatient/outpatient treatment program and aftercare recommendations as determined by his social worker; (c) that the respondent cooperate with the treatment plan and follow the rules at any living facility as arranged by his social worker; (d) that the respondent consent to admission or re-admission to a hospital or other appropriate care facility as determined by the respondent's social worker in the event of a relapse; (e) that the respondent take drugs or medications only as prescribed, and abstain from the use of any non-prescribed drugs or alcohol; (1) that the respondent see a psychiatrist and/or therapist as frequently as recommended; (g) that the respondent engage in no behavior which is threatening or injurious to self or others; (h) that the respondent participate in any day treatment program or community support services; (i) that the respondent participate in family therapy if recommended; (j) that the respondent sign releases of information authorizing his social worker and the various service providers to exchange information; and (k) that the respondent cooperate with his social worker as determined." On November 21, 2003, Mr. Markingson agreed to participate in the Caf Study. Prior to signing the informed consent, he underwent an evaluation with Jeanne Kenny, a Study coordinator, and Liz Lemke, an assistant working on the Study. Mr. Markingson passed the evaluation and was able to provide information about potential side effects, things expected of him, and his right to withdraw from the Study at any point in time. Thereafter, Mr. Markingson read the consent form, had the consent form read to him, and signed the consent form in the presence of Dr. Olson and Ms. Kenney. The informed consent set forth the purpose of the Study, the Study sponsor, Mr. Markingson's right to withdraw from the Study at any time, and alternative care and treatment available to Mr. Markingson. Mr. Markingson had the opportunity to ask any questions and raise any concerns prior to signing the information consent. Ultimately, he agreed to participate and signed. Despite signing the informed consent to participate in the CAF Study, Mr. Markingson did not begin the medication for that Study until December 5, 2003. He continued on Risperdal. He was slowly tapered off the Risperdal after December 5, 2003.
Mr. Markingson's first screening visit for the CAF Study occurred on November 24, 2003. A history of Mr. Markingson's onset of his mental illness was taken at that point in time. It was noted that the medication he was taking at the time of that visit was Risperdal and Ativan pm. The diagnosis was schizophrenia paranoid type, to rule out psychosis NOS and schizophreniform. It was noted that the patient did in fact meet the criteria for schizophrenia, and therefore did meet the diagnostic criteria for the trial. By November 25, 2005, Mr. Markingson was noted to be tolerating his Risperdal without difficulty. He also appeared to be gaining more insight into his prior delusional and paranoid behavior. Mr. Markingson reported at that point in time that he was having tension with his mother and was noted to be upset with her for her decision to not allow him to reside in her home post discharge. On November 26, 2003, Mr. Markingson met for the first time with his case manager and/or assigned social worker from Dakota County, David Pettit. During this meeting, Mr. Pettit met with Dr. Olson, Ms. Weiss and Mr. Markingson. At that point in time, Dr. Olson presented the CAFE Study to Mr. Pettit for his review and consideration. Mr. Pettit acknowledged that he believed that the care and treatment provided in the CAFE Study was reasonable and appropriate. He also stated that in his opinion, this provided Mr. Markingson with more interaction with his medical care providers than if he was discharged in the normal fashion. Ultimately, Mr. Pettit agreed to allow Mr. Markingson to participate in the CAFE Study. On December 3, 2003, Dr. Olson did an additional assessment of Mr. Markingson for the CAFE Study. Mr. Markingson indicated that he was working on being comfortable with the fact that he had psychosis. He also indicated a willingness to move to a group home. Once again, Mr. Markingson consented to treatment and to his participation in the CAFE Study.
r
On December 8, 2003, Mr. Markingson was discharged from FUMC. He was being transferred to Theodore I House run by Boston Health Care Systems. The Theodore I House ("Theo House") at the time was a Rule 36 facility with around-the-clock staff The decision to have Mr. Markingson at this facility was based upon the recommendations of Mr. Pettit. Dr. Olson's discharge diagnosis on December 8, 2003, was psychosis NOS, probable schizophrenia, and questionable history of alcohol abuse versus dependence. Mr. Markingson was noted to have mild hypothyroidism and had been placed on Synthroid. Over the course of Mr. Markingson's hospitalization, Dr. Olson became aware of the fact that he and his mother had a stressful relationship. Further, according to the history provided by Ms. Weiss, she and her son had not had contact for a substantial period of time. Dr. Olson noted that throughout Mr. Markingson's hospitalization, he remained guarded and superficial, although he did admit to having unusual and delusional thoughts. Dr. Olson also noted that Mr. Markingson continued to minimize his mental illness and the events leading up to his hospitalization.
CAF Study
The CAF Study was a 52 week randomized, double-blind, flexible dose multicenter study to evaluate the overall effectiveness, as measured by discontinuation rates of Olanzapine, Quetiapine and Risperidone in patients early in the course of psychotic illness. There were 24 sites throughout the United States where the CAFE Study was conducted. Joseph P. McEvoy and Jeffrey Lieberman served as the head research physicians of the Study. The Study was sponsored by Astrazeneca Pharmaceutical Company. A total of 400 patients were randomly assigned to treatment with one of the three drugs. The University of Minnesota was one of the site locations. Dr. Olson served as the principal investigator at the University of Minnesota site, with Dr. S. Charles Schulz and Dr. John Vuchetich serving as co-investigators. The CAF Study was modeled after the CATIE Study that had been conducted by the National Institute of Mental Health (NIMH). That Study was conducted to determine the longterms effects and usefulness of antipsychotic medications in persons with schizophrenia. The Study tested the anti-psychotic medications Olanzapine, Quetiapine, Risperidone, Clozapine and Ziprasidone, as well as Perphenazine and Fluphenazine Decanoate. The CATIE Study lasted for approximately 18 months. The majority of sites which conducted the CAFE Study, also participated in the CATIE Study. The CAFE Study was set up to mimic real-world clinical care. That is a distinct difference in the CAFE Study from other types of clinical research. Mr. Markingson attended 11 visits during his participation in the Caf Study.
SUMMARY OF ASSESSMENT RATINGS AT CAFE VISITS
D. and Visit # Screen 11/24/ 03 Baseline 12/5/0 3 Visit 1 12/11/ 03 Visit 2 12/19/ 03 Visit 3 12/24/ 03 Visit 4 12/31/ 03 fl Visit Visit 6 5 1/16/0 1/8/0 4 Visit 7 1/30/04 Visit 8 2/13/ 04 Visit 9 3/2/0 4 Visit 10 3/31/0 4 Visit 11 4/28/04
PANSS Positive Symptoms Negative Symptoms Calgary Depression Rating Scale * Suicide Sub-rating Positive and Negative Syndrome Scale Clinical Global Impressions Adverse Event/Side Effects Abnormal Involuntary Movement Scale Barnes Rating for Drug Induced Akathisia Simpson Angus Abbrev Medication Adherence Alcohol/Drug Use Scale 23 not complete 5 44 4 None 1 40 3 None 13 11 10 7 11 9absent 12 10 9 10 7 9 7 9 9 7 7 9 7 9 9 7 10 9 13 20 9 10 18 9
1 45 3 None 2 3sleepines s
1 35 2 None
1 32 2 2 sleepiness 2- insomnia 0 0 0 9
1 35 2 None
1 36 2 None
1 52 4 None
1 55 3 None
0 0 0 1abstinent 32 98 16
0 0 0 9
0 0 0 8
0 0 0 8 2alcoho I 32
0 0 0 8 1abstinen t 34
0 0 1 8 2 alcohol 27
8 1 abstinent 30 92 22
Health Care Service Utilization Heinrich Carpenter Qp-'iiv of Life I and Treatment AI., ..4e
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These rating scales demonstrate an improvement in the positive symptoms of schizophrenia seen with treatment and the low level of schizophrenia and depressive symptoms throughout the duration of the Study. The positive and negative scales have 30 items grouped into positive, negative and general subscales. The November 24, 2003 screening retrospective rating of 5 selected positive symptom items totaled 23, indicative of moderately severe symptomology (23/5 = 4.6; 4 = moderate, 5=moderate severe). However, by the time of the baseline ratings, Mr. Markingson's score on the full 7-item subscale had dropped to 13 and remained in the range of 7-13 for the entire six months prior to his death. His scores of 7-13 represent a near total resolution of psychosis showing a marked improvement. Further, these scores reflect that Mr. Markingson's delusional thoughts, hallucinations and paranoia were nearly totally absent. The PANS S Ratings had minimum scores of 7 for positive and negative subscales and 16 for the general symptom subscale. 1VIr. Markingson's negative subscales scores increased from 11 at his baseline visit to 18-20 by visits 10 and 11; his general scores went from 20 at baseline to 26-28 at visits 10 and 11. These scores are in the minimal to mild range, and as reflected in the clinical notes, a moderate deterioration in self-care and grooming. In general, antipsychotic medications exert their therapeutic benefit almost exclusively on positive symptoms, and there is no requirement to change medication due to an increase in negative symptoms. The medication that Mr. Markingson was assigned in the Study was learned after his death to be Seroquel, also known as Quetiapine. Each capsule of the Study medication contained 100 mg of Quetiapine. The maximal dose was 8 capsules per day, corresponding to a total maximum dose of 800 mg. From December 5, 2003 to December 10, 2003, Mr. Markingson was taking two pills per day. From December 11, 2003 to December 13, 2003, he was taking a total of four pills per day. From December 14, 2003 to December 19, 2003, he was taking a total of five pills per day. From December 20, 2003 through March 31, 2004, Mr. Markingson was taking a total of 7 pills per day. From April 1, 2004 onward, he was taking a total of 8 pills per day. At that point, he reached the maximum dose of 800 mg. of Seroquel. 1. Dr. Olson
Dr. Olson provided care and treatment to Mr. Markingson throughout the course of his hospitalization. In addition, Dr. Olson saw Mr. Markingson after his discharge. His documented visits with Mr. Markingson occurred on December 11 and 19, March 2 and 31, and April 9. All of these visits were very lengthy; 30 minutes to one hour. Dr. Olson also recalled speaking with Mr. Markingson at his January 30, 2004 visit. This meeting lasted 15 minutes to one-half hour. Therein, Dr. Olson addressed concerns about Mr. Markingson's medication compliance. He advised Mr. Markingson about the importance of medication and what could happen if he stopped. In addition, Dr. Olson was present at several visits that were conducted by Jeanne Kenney. Ms. Kenney was the Study coordinator who had been trained to do the necessary testing for the Study. At those visits where Mr. Markingson was evaluated by Ms. Kenney, she performed symptom ratings, side effect assessments, psychosocial education sessions, and other
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components of the Study. Dr. Olson testified that he often came in midway through those visits with Ms. Kenney and Mr. Markingson. When this occurred, Dr. Olson would examine Mr. Markingson and assess his condition. He would provide appropriate direction to Ms. Kenney about Mr. Markingson's assessment, medication and ongoing needs. In addition, Dr. Olson and Ms. Kenney would discuss all of her findings and the progress of Mr. Markingson. This would occur while Mr. Markingson was still at FUMC/ARC. Ms. Kenney and Dr. Olson would discuss whether or not Mr. Markingson was showing signs of relapse, possible side effects, or if there was any other major problem that had presented. Dr. Olson noted that he was available at all times to see Mr. Markingson if such a problem arose. Mr. Markingson was also participating in a day treatment program at FUMC. The multidisciplinary team at the day treatment facility met monthly to discuss clients. Dr. Olson participated in those monthly meetings. During those monthly meetings, Dr. Olson and the day treatment team would discuss Mr. Markingson's behavior and progress. Dr. Olson also recalls having 2-3 private conversations with Dan Buse, Mr. Markingson's primary therapist in the day treatment program, regarding Mr. Markingson's mental state, progress and his mother's concern about his ongoing alleged psychosis.
2.
Dr. Schulz saw Dr. Markingson on one occasion during his hospitalization at FUMC. That visit occurred on November 29, 2003. Dr. Schulz had reviewed Mr. Markingson's medical chart and interviewed him. Mr. Markingson was also examined by Dr. Schulz. Dr. Schulz found that the patient's thought process was logical, his mood was pleasant, and that his affect was appropriate. Dr. Schulz, as a co-investigator in the CAF Study, did not have any one on one visits or evaluations with Mr. Markingson. He received 2-3 letters from the patient's mother, Mary Weiss, in March and April of 2004. After having received these letters from Ms. Weiss, Dr. Schulz investigated her concerns. Dr. Schulz met with Dr. Olson and Jeanne Kenney to discuss Mr. Markingson's involvement in the CAFE Study. That conversation included a review of Mr. Markingson's progress, medication use, and overall mental health. Dr. Schulz then crafted a response to Ms. Weiss addressing each of her concerns. Dr. Schulz, as a co-investigator on the Study, gave 10% of his overall time to the project. In addition to serving as a co-investigator on the Study, Dr. Schulz is also the head of the Department of Psychiatry at the University of Minnesota. His role as a co-investigator was to be available as a backup rater for Dr. Olson if that was necessary. In addition, he was always available to Dr. Olson to answer any questions he might have, to discuss the progress of the study, or to discuss individual patients participating in the Study. As previously indicated, Dr. Schulz is also the head of the Department of Psychiatry at the University of Minnesota. The majority of his duties are administrative in nature. He also does clinical work each year for 2-4 weeks working as an attending psychiatrist in the inpatient service. He also sees outpatients for about four hours per week. During that timeframe, he will
12
be teaching residents and conducting supervision over his entire staff. Dr. Schulz also monitors all of the physicians, fellows, residents, and other staff members working in the Department of Psychiatry at the University of Minnesota. 3. Eagan Counselinjir Center
For individual therapy, Mr. Markingson was seen by Dr. Arlow Andersen, Ph.D. LP, of the Eagan Counseling Clinic located in Eagan, Minnesota. Dr. Andersen saw Mr. Markingson on December 11, 2003, January 12, 2004, February 16, 2004, March 29, 2004, and April 26, 2004. Each of Dr. Andersen's visits with Mr. Markingson lasted approximately one hour. This one-on-one therapy was a part of Mr. Markingson's discharge plan from the hospital. It was also part of the outpatient work suggested by Mr. Pettit as a part of Mr. Markingson's stay of commitment. Dr. Andersen was aware of Mr. Markingson's participation in the CAF Study. That information was learned from Mr. Markingson. In each of Dr. Andersen's visits, he found Mr. Markingson's thought process to be logical and coherent. Dr. Andersen also found Mr. Markingson to have good insight and good judgment. In each of Dr. Andersen's visits, he assessed whether or not Mr. Markingson was showing signs of halm to himself or others. In each of his visits, he noted that this was either low without plan or absent. In fact, on his last visit with Mr. Markingson on April 26, 2004, he noted that any risk to self was absent. Dr. Andersen testified that he did not believe that Mr. Markingson showed signs of being suicidal during their last visit. They also discussed the fact that Mr. Markingson's stay of commitment had been extended at his last visit. Mr. Markingson reported to Dr. Anderson that he did not object to the extension because he realized he was not prepared to return to California. 4. Day Treatment
Mr. Markingson participated in adult mental health day treatment at FUMC. This program was recommended by his social worker, David Pettit, as well as Dr. Olson. His participation was from January 14, 2004 through May 5, 2004. He was seen by Daniel Buse, HSW LLCSW, and Len Bennati, OTR/L. Mr. Markingson attended day treatment on Monday, Wednesday and Friday each week for three hours per day. Two hours of the visits were in group therapy, and one hour was dedicated to occupational group therapy. Mr. Markingson had been referred to day treatment to provide structure, support and education about his mental illness. The medical records of Mr. Buse indicate that throughout Mr. Markingson's stay in day treatment, he presented as stable and denied any psychotic symptoms. Mr. Markingson also willingly acknowledged past delusional thoughts, and recognized that his thoughts were bizarre in nature and content. Mr. Buse acknowledged that on occasion, Mr. Markingson presented with some negative symptoms which included some effect flattening, social withdrawal and avoidance. Mr. Buse noted that Mr. Markingson had excellent attendance throughout the course of his participation in day treatment,
13
Mr. Buse noted in his discharge summary that Mr. Markingson indicated a willingness to be discharged from day treatment as of May 5, 2004. Similarly, Mr. Bennati, in charge of his occupational therapy, found that Mr. Markingson acknowledged his diagnosis of schizophrenia and was receptive to continuing his medication use. Mr. Markingson's presentation in occupational therapy was noted throughout to be reserved and quiet. Some negative symptoms noted by Mr. Bennati were that Mr. Markingson had a blunted effect, on occasion appeared disheveled in his appearance, and at times was withdrawn. However, Mr. Buse and Mr. Bennati both thought Mr. Markingson was mentally stable enough to be discharged from day treatment. Mr. Markingson graduated from his day treatment program on or about May 5, 2004. He rarely missed his scheduled appointments. The records from all of his providers seemed to indicate that he was ready for his transition into independent living, and that he was committed to seeking further care and treatment for his ongoing mental illness.
5.
Theodore I House
After being discharged from FUMC, Mr. Markingson resided in a group home. This home was a Rule 36 facility known as Theodore I House ("Theo House") run by Boston Health Care. This facility was comprised of clients who were mentally ill, but not developmentally disabled. The group home provided 24 hours a day, 7 days a week staff care and monitoring. The staff notes and depositions from staff members indicate that Mr. Markingson was quiet, reserved, but never exhibited delusions, hallucinations, or paranoid thinking. Mr. Markingson was a resident of Theo House from December 8, 2003 until the time of his death on the very early morning hours of May 8, 2004. On or about January 23, 2004, the staff at Theo House became somewhat suspicious that Mr. Markingson may be cheeking or palming his medication. In an effort to stop that behavior, the staff put into a place a protocol where Mr. Markingson was required to take his medication straight from a cup, not allowing him to place it in his hand; he had to consume his medication in staff presence, and had to stay in the presence of staff for several minutes to ensure that he swallowed the medication. This protocol began shortly after January 23, 2005, and persisted up until the time of Mr. Markingson's death. Staff believed Mr. Markingson continued to take his medication as prescribed up until the time of his death. According to the staff notes from Theo House, Mr. Markingson accepted extension of his stay of commitment. Further, the staff notes reflect that Mr. Markingson was looking forward to transitioning into his own apartment and living independently. Staff notes and depositions indicate that no one had any reason to believe that Mr. Markingson was considering suicide or exhibiting behavior which would demonstrate he had suicidal ideation.
Assessment and Opinions
1.
In the opinion of Dr. Dunner, Dr. Olson did not violate the standard of care by having three simultaneous roles in regard to the care and treatment he rendered to Dan Markingson.
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Based upon the training, experience, and knowledge of Dr. Dunner, it is reasonable and appropriate for an individual to serve as a principal investigator in a clinical trial, to be the personal psychiatrist of a clinical trial, and also to be the primary care psychiatrist for a patient. Dr. Dunner will testify that it is possible for a conflict to occur if one assumes all three roles. However, according to Dr. Dunner, this is standard practice in clinical research. Dr. Dunner believes Dr. Olson was aware of this potential conflict and undertook necessary steps to avoid these conflicts. Therefore, Dr. Olson satisfied the standard of care in each of these roles according to Dr. Dunner. Dr. Olson in no way violated the ethical code of conduct nor did he violate the applicable standard of care. It is the opinion of Dr. Dunner that the Nuremburg Code, Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practice Guideline, and FDA Regulations and Guidelines are simply guidelines. These guidelines do not set forth the standard of care by which to judge conduct of research physicians, principal investigators, or primary care psychiatrists. These are simply guides which set forth ethical considerations which, in some instances, must be reviewed and accounted for in clinical trials. Further, these guidelines cannot be conclusively considered the standard of care required for physicians, research or otherwise. Dr. Dunner will opine that in obtaining informed consent from Mr. Markingson to participate in the CAFE Study, reasonable and appropriate methods were utilized. In his opinion, the standard of care was satisfied when obtaining informed consent from Mr. Markingson. Informed consent is a process and is not limited to the signature on a single document. Dr. Olson followed all of the steps necessary to ensure that Mr. Markingson was not only competent to give informed consent, but actually willingly agreed to participate in the CAF Study. As previously indicated, Mr. Markingson had been hospitalized since November 12, 2003. On or about November 13, Mr. Markingson began taking Risperdal. The notes reflect that the Risperdal had the desired effect on Mr. Markingson by helping him control his psychotic symptoms. He remained on Risperdal from November , 13 until December 5, 2003, when he began to taper off of the Risperdal and began the CAFE Study medication, later learned to be Seroquel. During that timeframe, Mr. Markingson's psychotic symptoms began to stabilize, he was no longer having active hallucinations or delusions, and his thought processes were described to be reactive and organized. Further, he had coherent and clear thoughts. In the opinion of Dr. Dunner, Mr. Markingson's medical records revealed that he was competent to give informed consent on November 21, 2003. A neuropsychological examination performed by Erin Holker, Ph.D. LP on November 18, 2003, indicates that by that date Mr. Markingson did not have cognitive impairments. Specifically, Dr. Holker's report indicates that Mr. Markingson's overall intellectual functioning was in the superior range. Further, Dr. Holker noted that Mr. Markingson did not have cognitive difficulties that would interfere with his ability to actively participate in his own treatment. In the opinion of Dr. Dunner, Mr. Markingson was able to provide informed consent. The informed consent form was signed by Mr. Markingson on November 21, 2003. In the opinion of Dr. Dunner, Mr. Markingson was competent and able to understand the CAFE
15
Study, and also to understand the informed consent process at that time. Mr. Markingson remained competent throughout his participation in the CAFE Study, and according to Dr. Dunner, was able to give ongoing informed consent which satisfied the applicable standard of care. Dr. Dunner will testify that it was reasonable and appropriate to have Jeanne Kenney , participate in the informed consent process. She had been adequately trained through the CAFE Study on competence as well as doing the competency evaluation. Further, she had extensive knowledge about the CAFE Study, and therefore, was a reasonable and appropriate person to participate in the informed consent process. Dr. Dunner will also opine that Dr. Olson's participation in obtaining informed consent from Mr. Markingson was reasonable, appropriate and was within accepted standard medical care. Dr. Olson followed every precaution to ensure that Mr. Markingson was competent to participate in giving informed consent. Further, Dr. Dunner will opine that Dr. Olson reasonably presented the CAFE Study as alternative care and treatment and did not coerce Mr. Markingson into participating. In the opinion of Dr. Dunner, the informed consent process in no way caused or contributed to Mr. Markingson's death. Dr. Dunner will testify that there was nothing about Mr. Markingson's being under a stay of commitment which barred his participation in the CAFE Study. There were no legal limits that would have prohibited Dr. Olson from having a person under a stay of commitment participate in a clinical trial. Dr. Dunner will opine it was reasonable and appropriate for Dr. Olson to ask Mr. Markingson to voluntarily participate in the CAFE Study. Dr. Olson's actions were within accepted standards of medical practice. , Dr. Dunner will testify that Mr. Markingson was not coerced into participating in the CAFE Study. Further, Dr. Dunner will testify that the stay of commitment did not order Mr. Markingson to participate in the CAFE Study. Dr. Olson simply presented the CAFE Study as alternative care and treatment for Mr. Markingson. Dr. Dunner will opine that Mr. Markingson's participation in the CAFE Study was reasonable and appropriate care, and that Mr. Markingson was not in any way forced or coerced into participating in the Study. Dr. Dunner is also supportive of the informed consent document utilized in the CAF Study. In his opinion, this document reasonably set forth the risks and benefits of participating in the CAFE Study. It stated the names of all of the study investigators. It also set forth the study sponsor, Astrazeneca. More importantly, it set forth information that Mr. Markingson's participation in the Study was voluntary and that he could withdraw from the Study at any point in time. Dr. Dunner will opine that the document set forth a reasonable and appropriate amount of alternative care which Mr. Markingson could have sought. Dr. Dunner will also testify that the document did not exaggerate nor unduly emphasize any benefits of Mr. Markingson's participation in the Study. Thus, in the opinion of Dr. Dunner, the informed consent document in and of itself was reasonable and appropriate and satisfied the standard of care. Dr. Dunner will testify that it was reasonable and appropriate for Mr. Markingson to participate in the CAFE Study. The CAFE Study utilized three FDA-approved antipsychotic
16
medications. No placebo was involved in the Study. In the opinion of Dr. Dunner, this is an exceptionally important aspect of the CAFE Study. At no point in time was Mr. Markingson at risk of having his psychotic symptoms go unmedicated. Instead, the CAFE Study involved three antipsychotic medication which have a marked impact on the positive symptoms, some negative symptoms, and psychotic indications for one with schizophrenia. Thus, in the opinion of Dr. Dunner, Mr. Markingson's participation in the CAFE Study was reasonable, appropriate and satisfied the standard of care. Dr. Dunner has reviewed all of the medical records involved in Mr. Markingson's care and treatment. In his opinion, it is absolutely clear that Mr. Markingson suffered from schizophrenia. There is absolutely no basis to deduce any other diagnosis of the patient. Dr. Dunner believes that Dr. Olson took the appropriate amount of time to assess the patient and to determine his diagnosis. Dr. Dunner is supportive of the diagnosis reached by Dr. Olson for Mr. Markingson. Dr. Dunner will opine that there is no evidence that Mr. Markingson was bipolar. He will concede that it was appropriate to rule out bipolar as a potential diagnosis for Mr. Markingson. However, in his opinion, under no uncertain terms, Mr. Markingson was not bipolar. Thus, Mr. Markingson met the Study protocol and was appropriately enrolled in the Study. Dr. Dunner will also opine that Mr. Markingson had substantially more monitoring and involvement with mental healthcare professionals than he would have received had he been seen in the standard method. In a standard care setting, Mr. Markingson would have had long periods of time without being seen by his psychiatrist. Further, he would have been responsible for taking his own medication with very limited monitoring. Due to Mr. Markingson's involvement in the CAFE Study, he was receiving substantially more monitoring that he would have received in standard private practice. In addition to the greater amount of monitoring he was receiving because of his participation in the CAFE Study, he was also receiving a great deal of care through his participation in the adult day treatment program at FUMC, by being seen by an individual therapist one time a month, living at Theo House and having 24 hour around the clock care, and the additional monitoring of his county case manager. According to Dr. Dunner, the standard of care and level of monitoring Mr. Markingson received, was above and beyond reasonable and appropriate care. In his mind, Mr. Markingson's involvement and monitoring by mental health professionals exceeded the level of accepted medical practice. Dr. Dunner will opine that the level of monitoring involvement with mental healthcare professionals Mr. Markingson had, did not in any way cause or contribute to his death. The evidence throughout the medical records indicate that Mr. Markingson was made well aware of his opportunity to seek alternative care and treatment, to seek a second opinion, and to withdraw from the CAFE Study. Providing Mr. Markingson with this vital information was reasonable and appropriate according to Dr. Dunner. Mr. Markingson was a competent adult and was the only one who could make that decision. Further, his county case manager never requested alternative care for him. Dr. Dunner will opine that providing Mr. Markingson with all of this information satisfied the standard of care. This did not cause or contribute to his death.
17
Dr. Olson also testified that he provided information to Mr. Markingson about alternatives to his participation in the CAFE Study. According to Dr. Olson, he described for Mr. Markingson his right to seek standard medical care. Providing verbal information, in addition to the written information received by Mr. Markingson, was reasonable and appropriate according to Dr. Dunner. Dr. Dunner will testify that providing this information to Mr. Markingson in no way caused or contributed to Mr. Markingson's cause of death. Dr. Dunner is of the opinion that it was reasonable and appropriate to seek an extension of Mr. Markingson's stay of commitment in May 2004. According to the medical records, as well as the deposition testimony, in March and April 2004, Mr. Markingson began to comment upon his desire to return to California. He indicated that he was going to travel there without any realistic financial planning to get there, and he did not have in place any healthcare system which could continue to address and assist him with his ongoing mental illness. Dr. Dunner will opine that there is absolutely no evidence that the stay of commitment was sought for any other reason than to ensure appropriate care and treatment for Mr. Markingson. There is absolutely no evidence that the stay of commitment was sought based upon a desire to retain Mr. Markingson in the CAFE Study. Further, Dr. Dunner will opine that there was no coercion by Dr. Olson to have Mr. Markingson continue to participate in the stay of commitment. The decision to extend the stay of commitment was reasonable and appropriate and satisfied the standard of care according to Dr. Dunner. Dr. Dunner will opine that based upon his review of the PANSS scores and records, in his opinion, Mr. Markingson was experiencing sporadic signs of depression. However, Dr. Dunner does not believe that there was a gradual deterioration over time that ultimately led to Mr. Markingson's death. Dr. Dunner believes that Mr. Markingson experienced sporadic ups and downs which would be typical for a person suffering from schizophrenia and dealing with that mental health disorder. Dr. Dunner does not agree that Mr. Markingson was in a gradual spiral down in his mental health condition which caused or contributed to his death. Therefore, Dr. Dunner will opine that Dr. Olson reasonably and appropriately monitored Mr. Markingson. Mr. Markingson was not showing signs of a gradual spiral and down turn in his mental health condition. Therefore, Dr. Olson's care and treatment to Mr. Markingson was in accord with accepted standards of medical practice. Dr. Dunner is also prepared to address the assertion that Dr. Olson should have placed Mr. Markingson on a different antipsychotic medication. The use of Seroquel, or any of the antipsychotic medication in the Study, was reasonable and appropriate care and treatment. In the opinion of Dr. Dunner, the use of Seroquel did stabilize Mr. Markingson and substantially reduced and minimized his psychotic symptoms. The ongoing problems experienced by Mr. Markingson were negative symptoms from his underlying condition. Dr. Dunner will testify and explain that negative symptoms generally are not easily treated through any medication. Dr. Olson did provide good clinical care both as Mr. Markingson's inpatient psychiatrist, as well as the principal investigator and Study physician for the CAFE Study, according to Dr. Dunner. Dr. Olson saw Mr. Markingson on a consistent and regular basis throughout his hospitalization at FUMC. Further, Dr. Olson saw Mr. Markingson on December 11 and 19,
18
2003. Thereafter, he saw him on January 30, March 2, 31, and April 9, 2004. Dr. Olson testified that there were several visits from December through February where he saw Mr. Markingson at the end of his CAFE visits during which time he met with Mr. Markingson and evaluated him. In addition, Dr. Olson was meeting once a month with the day treatment staff to discuss Mr. Markingson's progress and overall wellbeing. Dr. Olson would also have regular interaction with Jeanne Kenney and would discuss her observations of Mr. Markingson, as well as her assessments of his progress. Dr. Olson interacted with IVIr. Markingson and evaluated him a substantial amount according to Dr. Dunner. The care and treatment rendered by Dr. Olson was reasonable and appropriate care. By taking the additional steps to interact with other persons providing care to Mr. Markingson, Dr. Olson took an additional step above and beyond the necessary standard of care. In the opinion of Dr. Dunner, Dr. Olson satisfied the standard of care and in no way did his care and treatment cause or contribute to Mr. Markingson's death. According to Dr. Dunner, there is absolutely no validity to the allegation that Dr. Olson was an "absent" principal investigator. Dr. Olson tookhis role as Mr. Markingson's primary , care psychiatrist, the principal investigator of the CAFE Study, and the physician for the CAFE Study very seriously. The care and treatment he provided to Mr. Markingson was at all times reasonable and appropriate. In no way did the care and treatment rendered by Dr. Olson as the principal investigator of the Study, the Study physician, nor as Mr. Markingson's primary caregiver, in any way cause or contribute to Mr. Markingson's death. Dr. Dunner will also opine that it was reasonable and appropriate to have Jeanne Kenney participate in the evaluations and diagnostic interviews with Mr. Markingson. Ms. Kenney received the appropriate training and experience to do that testing. Further, she consulted with Dr. Olson on each of her visits with Mr. Markingson. According to Dr. Dunner, this was a reasonable and appropriate method of assessing this patient. Further, he is of the opinion that this satisfied the standard of care and in no way caused or contributed to Mr. Markingson's death. Dr. Olson also reasonably and appropriately considered the concerns being raised by Ms. Weiss. The record reflects that Ms. Weiss sent Dr. Olson two letters in November 2003. Those letters set forth some concerns she had about her son's participation in the CAFE Study, and alleged ongoing psychotic symptoms. After those two letters, Dr. Olson did not receive any further written communication from Ms. Weiss. He also on occasion received messages from Ms. Weiss raising her concerns. Dr. Olson took into consideration these concerns. He would consider that information against the presentation that Mr. Markingson made at his CAFE Study visits. In addition, he would weigh these concerns against information being received from the Theo House and the observations of Mr. Markingson being made during adult day treatment. In all instances, Mr. Markingson presented as being stable and no one could verify the concerns raised by Ms. Weiss. Thus, Dr. Olson reasonably and appropriately assessed and evaluated the concerns raised by Ms. Weiss. When those were determined to be without verification from other sources, Dr. Olson did not disregard those comments, but continued to consider them as a part of his ongoing care and treatment of Mr. Markingson. These assessments were reasonable, appropriate and satisfied the
19
applicable standard of care. In no way did this cause or contribute to Mr. Markingson's cause of death. Dr. Dunner is prepared to testify that Mr. Markingson was experiencing several stressors in his life which he believes may have contributed to Mr. Markingson's suicide. One of the principal stressors in Mr. Markingson's life was his mother. Dr. Dunner is of the belief that Ms. Weiss's desire to control her son and all of the care and treatment he received, as well as how he conducted his life, was a substantial stressor for Mr. Markingson. Dr. Dunner will also testify that when Mr. Markingson learned that his mother had gone to California and taken possession of his personal belongings without first consulting him, this was a significant stressor. Mr. Markingson clearly enjoyed his life in California. It was a place that offered him independence and was somewhere he had every intention of returning to after he was allowed to leave Minnesota. When Ms. Weiss removed Mr. Markingson's personal effects from California, she severed his ties with the one positive connection Mr. Markingson had to his past life. This severing of ties by Ms. Weiss, on behalf of Mr. Markingson, was a serious stressor. An additional stressor that Mr. Markingson was experiencing, according to Dr. Dunner, was his transition to independent living and attempts to obtain a job. In the experience of Dr. Dunner, oftentimes when a patient is facing change, it will create a great deal of stress and discomfort for the mentally ill. Mr. Markingson was no exception in that regard. The idea of living independently in an apartment and having the responsibility of a job were significant stressors for Mr. Markingson. Another stressor for Mr. Markingson was the continuation of his stay of commitment. Dr. Dunner felt that to a lesser extent, this was a stressor because it was a short-term limitation on Mr. Markingson's ability to return to California. It was clear that Mr. Markingson's intention was to return to California as soon as possible. However, the extension of the stay of commitment would have postponed his ability to do so for an additional six months. Dr. Dunner is prepared to opine that this too was an additional stressor. Despite all of these stressors, there was no reason for Dr. Olson to withdraw Mr. Markingson from the Study. Dr. Dunner will opine there were no clear warning signs that Mr. Markingson was potentially suicidal. He was not exhibiting signs of psychosis nor was he deteriorating. The behavioral assessment of suicide ideation consistently showed no evidence of suicide. Furthermore, none of his multiple clinicians, staff at Theo House, or apparently, residents at Theo House were aware of Mr. Markingson's being suicidal. Dr. Dunner will opine that it was reasonable and appropriate to have Mr. Markingson remain in the CAFE Study. The CAFE Study provided reasonable and appropriate care and was within the accepted standards of medical practice. Remaining in the CAFE Study did not in any way cause or contribute to Mr. Markingson's cause of death. Dr. Dunner will opine that there was no evidence that re-hospitalization for Mr. Markingson was clinically warranted. According to the information contained in his journal he was experiencing psychotic thinking, however, those thoughts were not conveyed to others.
20
Furthermore, there was no evidence in his journals that he was having suicidal thoughts. Mr. Markingson's condition had stabilized and he was not presenting with active hallucinations, delusions or paranoia. Mr. Markingson no longer was making threats against others or himself. In Dr. Dunner's opinion, hospitalization was neither necessary nor appropriate for Mr. Markingson. The decision to not re-hospitalize Mr. Markingson was not a cause or contributing factor to Mr. Markingson's death. Dr. Dunner will testify that those with schizophrenia have a greater rate of suicide than the average population. Individuals who are schizophrenic have the capability of committing suicide even if they are hospitalized in a locked ward. In the case of Mr. Markingson, he was receiving an exceptional amount of care and close monitoring. His decision to take his own life was not caused or contributed to by the care and treatment rendered by Dr. Olson as the principal investigator of the CAFE Study, Dr. Olson as primary care psychiatrist of the CAFE Study, or as Mr. Markingson's individual primary care psychiatrist. According to Dr. Dunner the toxicology report indicated Mr. Markingson had stopped taking his Caf Study medication (quetiapine). The fact that there was no presence of the medication in his blood indicates that Mr. Markingson had not been taking his medication for a few days prior to his suicide. Mr. Markingson's non-adherence to treatment in the few days prior to his death likely caused or contributed to his suicide. Dr. Dunner will testify that he did review the Department of Health and Human Services report regarding their review of the death of Mr. Markingson. In his opinion, there were , absolutely no adverse findings related to Dr. Olson, the University of Minnesota, the CAFE Study, nor Dr. Schulz. Dr. Dunner has also reviewed the investigation conducted by the Food and Drug Administration by Sharon L. Matson, Investigator, in January of 2005. Dr. Dunner will testify that the investigation conducted by the FDA found no adverse care and treatment by Dr. Olson, Dr. Schulz, or any other person involved in Mr. Markingson's care and treatment. The FDA found that Mr. Markingson's diagnosis of schizophrenia was reasonable and appropriate. Dr. Dunner also noted that the FDA found that the court order did not require Mr. Markingson's participation in the CAFE Study. Thus, there was no evidence of inappropriate coercion. The FDA investigator found that Mr. Markingson received more care than he would have received in standard medical care by his participation in the CAFE Study. The FDA also found that Mr. Markingson was in a state to give voluntary, informed consent on November 21,2003. The FDA also noted in their report that Mr. Markingson's continued participation in the Caf Study was appropriate and there was no clinical evidence of deterioration. According to Dr. , Dunner, the FDA report is proof of the excellent care and treatment Dr. Olson and the CAFE Study afforded to Mr. Markingson. Dr. Dunner will point out that not one of the other care providers involved in Mr. Markingson's care and treatment ever attempted to contact Dr. Olson. Dr. Dunner will opine that if Dr. Andersen, Mr. Pettit, the Theo House staff, or the day treatment staff, had any questions or concerns about Mr. Markingson's progress or stability in the CAFE Study, it would
21
have been incumbent upon them to contact Dr. Olson. According to Dr. Dunner, it is very telling that at no point in time did any of these care providers contact Dr. Olson with concerns about Mr. Markingson. Instead, individuals from each one of these facilities have indicated that they believed that Mr. Markingson was stable and did not need additional assessment by Dr. Olson. This reiterates that the care and treatment received by Mr. Markingson was reasonable and appropriate. Dr. Dunner is of the opinion that it was not necessary for Dr. Olson to obtain blood tests to verify Mr. Markingson's medication level. According to Dr. Dunner it is highly unusual for blood tests to be obtained. It appeared that Mr. Markingson was compliant with taking his Caf medication. Mr. Markingson was regularly attending all of his appointments with his various medical providers. He was not reporting having any active hallucinations or delusions. Mr. Markingson also did appear to exhibit any signs of significant deterioration. Given these circumstances, Dr. Dunner does not believe this type of case would call for an extreme measure like blood testing. Thus, the standard of care did not require Dr. Olson to acquire blood tests, urine tests or other laboratory testing to determine Mr. Markingson's medication level. In the opinion of Dr. Dunner, Dr. Olson at all times provided reasonable and appropriate care and treatment to Mr. Markingson. In his role as principal investigator of the CAFE Study, CAFE Study physician, and primary care psychiatrist to Mr. Markingson, he provided reasonable and appropriate care and treatment, all of which satisfied the standard of care. Further, in his opinion, in no way did the care and treatment provided by Dr. Olson cause or contribute to Mr. Markingson's death. Dr. Dunner will opine that the care provided by Dr. Olson, Dr. Schulz, the University of Minnesota Physicians, nurses, all other physicians, psychiatrists, psychologists, social workers, day treatment personnel, and Theo I staff was reasonable and appropriate. In his opinion, none of their care caused or contributed to Mr. Markingson's death.
2.
During Mr. Markingson's hospitalization, he saw Dr. Schulz on one occasion on or about November 29, 2003. Dr. Schulz was covering rounds at the hospital for Dr. Olson during that timeframe. Dr. Schulz performed a history and examination of Mr. Markingson during this visit. Dr. Schulz found Mr. Markingson's thought process to be logical and that his mood was pleasant and his affect was appropriate. He was noted to be on Risperdal at that time and Dr. Schulz continued the patient's use of that medication. In the opinion of Dr. Dunner, the care and treatment rendered by Dr. Schulz to Mr. Markingson on this single visit was reasonable, appropriate, and satisfied the standard of care. His examination and assessment of this patient, along with the continuation of Mr. Markingson's medication, was appropriate care. Dr. Dunner will opine that Dr. Schulz's care and treatment of this patient did not cause or contribute to his death. Dr. Dunner is also expected to testify and opine that Dr. Schulz did not violate the standard of care for a co-investigator of a clinical trial or as the head of the Department of Psychiatry. Dr. Dunner will opine that Dr. Schulz's activities in those capacities was within
22
accepted medical practice. Further, Dr. Dunner will provide the opinion that Dr. Schulz neither caused nor contributed to Mr. Markingson's death. According to Dr. Dunner, the evidence will show that Dr. Olson and the CAF Study treatment team were involved in obtaining informed consent from Mr. Markingson. Dr. Schulz did not interact with Mr. Markingson after his single visit with him , in the hospital. Dr. Schulz did not present to Mr. Markingson any information about the CAFE Study. Dr. Schulz did not make an assessment of Mr. Markingson's competence at any point in time during his hospitalization. Further, all of the evidence will show that Dr. Schulz in no way participated in the informed consent process conducted on November 21, 2003. In the opinion of Dr. Dunner, Dr. Schulz could not have violated the standard of care requirements for obtaining informed consent when he was not in any way involved in that process. Thus, Dr. Schulz's lack of involvement in the informed consent process could not have been a component or a causal factor in Mr. Markingson's death. Dr. Dunner will testify that the standard of care did not require Dr. Schulz to participate in the informed consent process. As a co-investigator of the CAF Study, Dr. Schulz was aware of the information contained in the informed consent document. That document had been reviewed by the Institutional Review Board at the University of Minnesota. That Board took into consideration the reasonableness and appropriateness of that document for use amongst human subjects. After making several changes to the document, the Institutional Review Board approved the use of that document which had been utilized to enroll other subjects in the CAFE Study for the year or more that it had been conducted at the University of Minnesota site prior to Mr. Markingson's involvement. Dr. Dunner is of the opinion that the information contained in the CAFE Study informed consent document was reasonable and appropriate. It is his opinion that that document fully set forth information about Mr. Markingson's right to withdraw from the Study, alternative treatment, the risks of the Study, and the benefits. To a reasonable degree of psychiatric and medical certainty, Dr. Dunner will opine that this document was reasonable, appropriate and satisfied the standard of care. In no way was the document exploitive or coercive. Dr. Dunner will also testify that as a co-investigator on the Study, Dr. Schulz was only responsible for the care provided to those patients he was seeing. Only the principal investigator on a study is responsible for the care of all of the patients. Dr. Schulz never saw Mr. Markingson as a participant in the CAFE Study. Dr. Dunner will also opine that Dr. Schulz was not involved in Mr. Markingson's stay of commitment. Nevertheless, Dr. Dunner will opine that regardless of Mr. Markingson's stay of commitment, he was still a reasonable and appropriate candidate to participate in the CAFE Study. Further, regardless of the fact that he was functioning under a stay of commitment, did not negate the fact that Mr. Markingson was competent and able to voluntarily agree to participate in the CAFE Study. Dr. Dunner will opine that it was reasonable and appropriate for Dr. Schulz, as a co-investigator of the CAFE Study and as the head of the Department of Psychiatry at the University of Minnesota, to allow Mr. Markingson to participate in the CAFE Study given his competence, voluntary choice to participate in the study, and approval of Mr. Markingson's case manager/social worker, David Pettit.
23
Dr. Dunner will opine that given his role in Mr. Markingson's care and treatment, Dr. Schulz was not obligated to ensure that Mr. Markingson obtained a second opinion. The medical records reflect that Mr. Markingson was satisfied with the care he was receiving from Dr. Olson and in the CAFE Study. The records also reflect that Dr. Olson, on several occasions, expressed to Mr. Markingson that he had the right to seek a second opinion, yet each time Mr. Markingson refused. The standard of care did not require Dr. Schulz to force or even suggest to Mr. Markingson that a second opinion was necessary. As previously stated in his opinions on Dr. Olson, Dr. Dunner will opine that acquiring a blood test to discern the level of antipsychotic medication in Mr. Markingson's blood was not required. Dr. Schulz had no reason to personally conduct such a test or to request that Dr. Olson or the CAFE Study staff perform such testing. Dr. Dunner will opine that blood level testing is done in the rarest of circumstances and certainly would not have been called for in this case. Dr. Schulz's position as co-investigator and department head did not require him to seek blood level testing for Mr. Markingson. Dr. Schulz did not violate the standard of care and did not cause or contribute to Mr. Markingson's death in this regard. Dr. Dunner will also address the suggestion that there was a conflict of interest based upon an alleged financial gain that Dr. Schulz would receive as a result of Mr. Markingson's participation in the CAFE Study. Dr. Dunner will opine that he has reviewed the records and does not see any evidence of a financial motivation which would have in any way impaired or hindered Dr. Schulz's judgment in regard to the care and treatment provided to Mr. Markingson. Further, there is no evidence of any financial misconduct in how Astrazeneca paid for the performance of the Study. Dr. Schulz took very seriously his role as the head of the Department of Psychiatry and as a co-investigator of the CAFE Study to ensure that all staff, including Dr. Olson, provided appropriate care to all patients and/or Study subjects. In the opinion of Dr. Dunner, Dr. Schulz reasonably and appropriately monitored the CAFE Study and was available to assist in any manner necessary if issues arose. He allowed Dr. Olson, a seasoned, skilled and highly knowledgeable member of his staff, to serve as the principal investigator of the CAFE Study. Dr. Dunner will opine that Dr. Olson's skill and knowledge level called for Dr. Schulz to allow Dr. Olson to conduct this Study independently. Dr. Schulz was, in the opinion of Dr. Dunner, right in that assessment as Dr. Olson did provide appropriate care. Therefore, Dr. Schulz satisfied the standard of care by allowing the CAFE Study to be conducted in the manner in which it was at the University of Minnesota. There is nothing about the way the CAFE Study was conducted that caused or contributed to Mr. Markingson's death. The way the Study was implemented at the University of Minnesota by Dr. Schulz and Dr. Olson under the direction of the IRB was reasonable and appropriate. According to Dr. Dunner, Dr. Schulz knew that Dr. Olson was a conscientious principal investigator, CAFE Study physician, and primary caregiver. Further, he knew he would do whatever was necessary to provide reasonable and appropriate care to Mr. Markingson. Dr. Olson did have reasonable and appropriate contact with Mr. Markingson throughout the course of his hospitalization and his aftercare prior to his death. Dr. Schulz reasonably and
24
appropriately monitored Dr. Olson's contact with Mr. Markingson, and all of the CAF Study participants, both as a co-investigator and as the head of the Department of Psychiatry at the University of Minnesota. Dr. Dunner is of the opinion that Dr. Schulz did reasonably and appropriately investigate and consider the information he received from Ms. Weiss. Further, Dr. Dunner will opine that Dr. Schulz's investigation of the subject matter was reasonable, appropriate and satisfied the standard of care. Dr. Dunner will also testify that the timely response by Dr. Schulz to Ms. Weiss's concerns about her son's participation in the CAFE Study satisfied the standard of care and did not in any way cause or contribute to Mr. Markingson's death. When Dr. Schulz received Ms. Weiss's correspondence, he contacted Jeanne Kenney and Dr. Olson to review Mr. Markingson's participation in the CAFE Study. Dr. Schulz testified that he spent more than one hour talking to them to discern whether or not there was any validity to the concerns she was making about Mr. Markingson's behavior, progress, and continued participation in the CAFE Study. Dr. Schulz extensively questioned both Ms. Kenney and Dr. Olson about her concerns, and after investigating that matter, felt satisfied that Mr. Markingson was progressing appropriately, his condition had stabilized, and that he was an appropriate candidate to be a participant in the CAFE Study. Dr. Schulz addressed each and every one of Ms. Weiss's concerns. He discussed Mr. Markingson's change in behavior and improvement in his condition since his participation in the CAFE Study. He also reiterated to Ms. Weiss that if Mr. Markingson was not responding to the CAFE medication or indicated a desire to withdraw, he could do so. Dr. Schulz advised Ms. Weiss that Mr. Markingson had not asked to be removed from the Study, and that his medication appeared to be helping with his symptoms. Further, Dr. Schulz reiterated to Ms. Weiss that Mr. Markingson had the right to seek a second opinion, but that decision was Mr. Markingson's alone. Finally, Dr. Schulz addressed Mr. Markingson's living situation and indicated to her that a trial run in a local apartment would certainly be better than Mr. Markingson's desire to return to California without supervision. The letter written by Dr. Schulz, in the opinion of Dr. Dunner, was reasonable, appropriate and satisfied the standard of care. Dr. Dunner will testify that in no way did Dr. Schulz's actions cause or contribute to Mr. Markingson's death. Dr. Dunner will testify that there was absolutely no evidence which would have indicated to Dr. Schulz that Dr. Olson was an absent physician or principal investigator. To the contrary, in the opinion of Dr. Dunner, Dr. Schulz appropriately reached the conclusion that Ms. Markingson was receiving reasonable and appropriate care in the clinical trial. There was absolutely no basis for Dr. Schulz to intervene into the care of Mr. Markingson or discontinue his participation in the Study. Dr. Schulz satisfied the standard of care and did not cause or contribute to Mr. Markingson's death. The only concerns about Mr. Markingson's care and treatment in the CAFE. Study came from Ms. Weiss. Federal requirements indicate that an Institutional Review Board is to receive information about concerns received from investigators conducting the Study. However, those are the concerns that are registered by the participants. Ms. Weiss was not a participant in the CAFE Study. It was not required that either Dr. Olson or Dr. Schulz report this information to
25
the Institutional Review Board, Quintiles or Astrazeneca ; Mr. Markingson did not personally lodge any complaints about his participation in the CAFE Study, the medication, nor any adverse effect he may have been experiencing. The standard of care did not call for Dr. Olson or Dr. Schulz to advise the Institutional Review Board, Quintiles, or Astrazeneca Pharmaceuticals. Dr. Dunner will also opine that Dr. Schulz did not have a duty to disclose to Ms. Weiss that he was a co-investigator on the CAFE Study in his response to her. That information had nothing to do with Mr. Markingson's care. Further, there is no proof it would have changed the care Mr. Markingson received. The standard of care did not require Dr. Schulz to disclose that information to her. Ms. Weiss was not a participant in the CAFE Study, was not a monitor of the CAFE Study, and was simply a person presenting concerns about a patient. Thus, Dr. Schulz's care and treatment did not cause or contribute to Mr. Markingson's death. Dr. Dunner will also opine that the fact that the Office of the Ombudsman, the Department of Health and Human Services, and the FDA all conducted investigations and studies into the outcome of this case. In the opinion of Dr. Dunner, each one of these investigating entities found that the standard of care had been satisfied and in no way did the care and treatment rendered by Dr. Olson, Dr. Schulz, or any person affiliated with the CAFE Study cause or contribute to Mr. Markingson's death. Instead, each of these entities found that the care and treatment provided to Mr. Markingson was reasonable and appropriate. Dr. Dunner will also point out that in each one of these investigations conducted, Dr. Schulz was not named nor was he indicated as a person whose actions were being investigated. Dr. Dunner will indicate that this information is striking because it demonstratively shows Dr. Schulz's role as both a co-investigator and the head of the Department of Psychiatry was not at any point in time questioned by these institutions. Further, not one entity believed that Dr. Schulz's role as a co-investigator, nor as the head of the Department of Psychiatry, caused or contributed to Mr. Markingson's death. In the opinion of Dr. Dunner, Dr. Schulz satisfied the standard of care both as a coinvestigator of the CAFE Study and as the head of the Department of Psychiatry at the University of Minnesota. Dr. Schulz's activities in each of those roles, was reasonable and appropriate. There is not any evidence, in the opinion of Dr. Dunner, as either a co-investigator or as the head of the Department of Psychiatry Dr. Schulz in any way caused or contributed to Mr. Markingson's death. Dr. Dunner will also opine that there was no evidence of bias or unethical judgment by Dr. Olson or Dr. Schulz as a result of Astrazenca's sponsorship of the study. According to Dr. Dunner, there is absolutely no evidence of unlawful payment to Dr. Olson or Dr. Schulz directly by Astrazeneca. The method of payment to the University of Minnesota was reasonable and appropriate. Further, there was nothing that violated the standard of care by having payments made to the University even if a portion of these payments went to support Dr. Olson's or Dr. Schulz's salaries. Dr. Dunner will also offer opinions about the employability of a patient suffering from schizophrenia. In his opinion, schizophrenia is a life long disease. People diagnosed with
26
have difficulty remaining medication compliant Further, persons with a diagnosis of schiwphrenia often experience several relapses throughout their life, and most arc rehospitalized ion at least one occasion in their life. All of these factors inhibit persons diagnosed with schizophrenia from the ability to obtain and retain stable, full-time employment. In his experience, regardless of ideation level, most will be unable to maintain employment and are reliant upon social security disability benefits as their sole means of support.
CERTIFICALM oertify that the foregoing statgmcnts and opinions arc true and correct to the best of knowledge and belief. I further certify that the above opinions are rendered to a reasonable my degree of medical and psychiatric certainty. These opinions may be supplemented or revised should there be additional discovery and/or informgion submitted or brought to my attention for
review.
David L, Danner, M,D, Subscribed and sworn to before me this 71 day ofti4azt 2007.
441
.si4r
beit it
/
*04.,
ary Public
IPASI.01
Dated:
Davi #120431 Angela MNe1son 40306617 OISLASON 84 IIUNTER LLP Attorneys for Stephen Olson, M.D., and Charles Schulz, M.D. 701 Xenia Avenue South, Suite 500 Minneapolis, MN 55416 Phone: 763-225-6000
1PUS:303304,1
27
Center for Anxiety and Depression 7525 SE 24th Street, Suite 400 Mercer Island, WA 98040 Office Ph: (206) 230-0330 Fax No: (206) 230-0336 E-Mail: dldunner comcastmet Birthdate: Birthplace: Marital Status: May 27, 1940 Brooklyn, New York Married (Peggy Jane Zolbert Dunner) Two children
Personal Data:
Education:
The George Washington University Washington, DC, 1958-1961 Washington University School of Medicine St. Louis, MO
Postgraduate Training:
Internship (rotating), Philadelphia General Hospital, Philadelphia, PA Residency in Psychiatry, Washington University School of Medicine (Renard Hospital) Clinical Associate Section on Psychiatry, Laboratory of Clinical Science, National Institute of Mental Health (U.S. Public Health Service)
Faculty Positions Held:
1965-1966
1966-1969
1969-1971
Columbia University College of Physicians and Surgeons, New York Assistant Professor of Clinical Psychiatry Associate Professor of Clinical Psychiatry University of Washington Professor Emeritus, Department of Psychiatry & Behavioral Sciences Professor of Psychiatry and Behavioral Sciences Vice Chairman for Clinical Services Director, Center for Anxiety and Depression
Hospital Positions Held:
1972-1976 1976-1979
Presbyterian Hospital, New York Assistant Attending Physician Associate Attending Physician New York State Psychiatric Institute, New York, NY Psychiatrist II Foundation for Depression and Manic Depression, Inc. Psychiatrist Consultant
1979-1989
1989-1997
Organizations: Academia, Medicinae & Psychiatrie Foundation, Inc. Fellow American Academy of Clinical Psychiatrists American Association for the Advancement of Science American College of Neuropsychopharmacology Scientific Associate Member Fellow Life Fellow Education and Training Committee -Chairman -Co-Chairman Progam and Scientific Communications Committee Task force to revise guidelines for clinical trials of psychotropic drugs Publications Committee Committee on Problems of Public Concern Constitution and Rules Committee Advocacy Committee American College of Psychiatrists Fellow Contributions Committee Co-Chair Chair Committee on Nominations
1992-Present 1988-Present 1970-1993 1975-1979 1979-1983 1983-2005 2005-Present 1983-1987 1984 1985 1987-1989 1990-1992 1993-95 1993 2001-2003 2003-2005 1984-Present 1993 1991-1996 1993-1994 1994-1996 1997-2000
Editorial Responsibilities: Editor, Psychiatrists In-Practice Examination (PEPE) - the American College of Psychiatrists, 2004 Editor-in-Chief, Comprehensive Psychiatry, 1997Editor, Video Journal of Psychiatry, 1993 Editorial Board, Journal for Affective Disorders, 1978-Present Editorial Board, Journal of Clinical Psychiatry, 1981-1987
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33, Farkas T, Dunner DL, and Fieve R.R: L-Tryptophan in depression. Biol Psychiat. 11:295-302, 1976, 34. Fieve RR, Milstoc M, Kumbaraci T, and Dunner DL: The effect of lithium on red blood cell cholinesterase activity in patients with affective disorders. Dis. Nerv, Syst. 37:240-243, 1976, Dunner DL, Fleiss JL, and Fieve RR: Lithium carbonate prophylaxis failure. Brit J. Psychiat. 129:40-44, 1976. Diamond SB, Rubinstein AA, Dunner DL, and Fieve RR: Menstrual problems in women with primary affective illness. 17:541-548, 1976,
35. 36.
Compr. Psychiat.
37.
Fieve RR, Kumbaraci T, and Dunner DL: Lithium prophylaxis of depression in bipolar I, bipolar II and unipolar patients. Amer. J. Psychiat. 133:925-929, 1976. Dunner DL, Fleiss JL, and Fieve RR: The course of development of mania in patients with recurrent depression. 133:905-908, 1976.
38.
39.
Dempsey GM, Dunner DL, Fieve RR, Farkas T, and Wong J: Treatment of excessive weight gain in patients taking lithium. Psychiat. 133:1082-1084, 1976.
40.
Dunner DL and Somervill JW: "Medical Treatments" in Abnormal Psychology, Rimm, DC and Somervill JW, eds. New York Academic Press, pp. 591-614, 1977, Dunner DL, Levitt M, Kumbaraci T, and Fieve RR: Erythrocyte catechol-o-methyltransferase activity in primary affective disorder. Biol. Psychiat. 12:237-244, 1977.
41.
46, Dunner DL, Heiber S, and Perel JM: The effect of L-tryptophan administration on the concentration of probenec d in plasma and cerebrospinal fluid in patients. Psychopharmacology 53:305-308, 1977. 47. Meltzer FEL, Kassir S, Dunner DL, and Fieve RR: Repression of a lithium pump as a consequence of lithium ingestion in manic depressive subjects. Psychopharmacology 54:113-118, 1977. Kim YB, Dunner DL, Meltzer FIL and Fieve RR: Lithium Erythrocyte: plasma ratio in primary affective disorder. 134, 1978.
48.
49.
Barkai Al, Dunner DL, Gross H, Mayo P, and Fieve RR: Reduced myoinositol levels in cerebrospinal fluid from patients with affective disorder. Biol Psychiat. 13:65-72, 1978. Dunner DL and Fieve RR: The Lithium ion: Its impact on diagnostic practice. In Psychiatric Diagnosis: Exploration of Biological Predictors, Akiskal HS and Webb WL, eds. Spectrum Publications, Inc., New York, 1978, pp. 233-246. Fleiss JL, Prien RF, Dunner DL, and Fieve RR: Actuarial studies of the course of manic-depressive illness. 362, 1978.
50.
51.
52. 53.
Dunner DL, Meltzer ELL, and Fieve RR: Metabolism of lithium in erythrocytes. McLean Hosp. J. 3:89-97, 1978, Dunner DL, Meltzer HI, and Fieve RR: Clinical correlates of the lithium pump. Amer. J. Psychiat, 135:1062-1064, 1978.
54, Patrick V, Dunner DL, and Fieve RR: Life events and primary affective illness. Acta Psychiatr. Scan& 58:48-55, 1978. 55. Dunner DL and Fieve RR: The effect of lithium in depressive subtypes. Neuropsychopharmacology, P. Deniker, C. Radouco-Thomas, and Al Villeneuve, eds. Pergamon Press, New York, 1109-1115, Vol. 2. Dunner DL, Igel GJ, and Fieve RR: Social adjustment in primary affective disorder. Amer. J. Psychiat. 135:1413-1413, 1978. Ruestow P, Dunner DL, Bleecker B, and Fieve RR: Marital adjustment in primary affective disorder. 1978.
56. 57.
58.
Cho JT, Bone S, Dunner DL, Colt E, and Fieve RR: The effect of lithium treatment on thyroid function in patients with primary affective disorder, Amer. J. Psychiat, 136:115-116, 1979. Schreiner HC, Dunner DL, Meltzer fit, and Fieve RR: The relationship of the lithium erythrocyte: plasma ratio to plasma lithium level.
59.
62, Roose SP, Numberger JI, Dunner DL, Blood DK, and Fieve RR: Cardiac sinus node dysfunction during lithium treatment. Amer. J. Psychiat. 136:804-807, 1979. 63. 64. Roose SP, Bone 5, Haidorfer C, Dunner DL, and Fieve RR: Lithium treatment in older patients. Amer. J. Psychiat. 136:843-844, 1979. Asnis GM, Asnis D, Dunner DL, and Fieve RR: Cogwheel rigidity during chronic lithium therapy. Amer. J. Psychiat. 136:1225-1226, 1979.
65. 66.
Colt EWD, Igel G, Fieve RR, and Dunner DL: Lithium associated nephropathy. Amer. J. Psychiat. 136:1098-1099 (letter to ed.), 1979. Liebowitz IvIR, Stallone F, Dunner DL, and Fieve RR: Personality features of patients with primary affective disorder. Scand. 60:214-224, 1979.
Acta Psychiat.
67.
Hensel B, Dunner DL, and Fieve RR: The relationship of family history of alcoholism to primary affective disorder. J. Affective Dis. 1:105-113, 1979, Rosenthal NE, Rosenthal LN, Stallone F, Fleiss J, Dunner DL, and Fieve RR: Psychosis as a predictor of response to lithium maintenance treatment in bipolar affective disorder. J. Affective Dis, 1:237-245, 1979. Dunner DL, Murphy D, Stallone F, and Fieve RR: Episode frequency prior to lithium treatment in bipolar manic depressive patients. Compr. Psychiat. 20:511-515, 1979. Dunner DL and Fieve RR: Catecholamine metabolizing enzymes and primary affective disorders. In Catecholamine: Basic and Clinical
68.
69.
70.
Frontiers, Usdin E, Kopin IJ, and Barchas Si, eds. Pergamon Press, New York, pp. 1908-1910, 1979.
71. 72. Numberger J, Roose SP, Dunner DL, and Fieve R.R.: Unipolar mania: A distinct clinical entity.
Dunner DL, Meltzer HL, and Fieve RR: "Clinical aspects of lithium efflux from erythrocytes" in Biological Psychiatry Today, Obiols J, Ballus C, Bonzales Monclus E, and Pujol J, eds. Amsterdam, Elsevier/North Holland Biomedical Press, pp. 1148-11 5 2, 1979. Fieve RR, Meltzer I-IL, Dunner DL, and Fleiss JL: "Lithium pump repression as an indicator of prophylactic response" in Biological Psychiatry Today, Obiols J, et al, eds., Amsterdam Elsevier/North Holland Biomedical Press, pp. 1123-1127, 1979.
73.
74, Dunner DL and Rosenthal NE: "Schizoaffective states" The Psychiatric Clinics of North America 2:441-448, 1979. 75. 76. Dunner DL: Rapid cycling bipolar manic depressive illness. The Psychiatric Clinics of North America 2:461-467, 1979, Goodnick PJ, Meltzer HL, Dunner DL, and Fieve RR: Repression and reactivation of lithium efflux from erythrocytes. Psychiat. Res. 1:147-152, 1979. Fieve RR, Meltzer HL, Dunner DL, and Fleiss JL: "Lithium pump repression as an indicator of prophylactic response" in Lithium/controversies and unresolved issues, Cooper TB, Gerson S, Kline NS, and Schou M, eds., Excerpta Medica, Amsterdam 1979, pp. 257-261, Dunner DL, Roose SP, and Bone S: "Complications of lithium treatment in older patients" in Lithium/controversies and unresolved issues, Cooper TB, Gershon S, Kline NS, and Schou M, eds., Excerpta Medica, Amsterdam, pp. 427-431, 1979. Fieve RR, Meltzer HL, Dunner DL: "Clinical trials with rubidium chloride in depressed patients" in Biological Psychiatry Today, Obiols J, Ballus C, Gonzales Monclus E, and Pujol J, eds. Amsterdam Elsevier/North Holland Biomedical Press, pp. 1128-1 131, 1979. Bone S, Roose SP, Dunner DL, and Fieve RR: Incidence of side effects in patients on long-term lithium treatment 137:103-104, 1980.
77.
78. 79.
80.
Amer. I. Psychiat,
81.
Georgotas A, Dunner DL, Meltzer HL, Solomon F, Fieve RR, and Gerson S: The importance of dietary control in metabolic studies of manic-depressive patients. Biol. Psychiat. 15:157-163, 1980. Goodnick PJ, Perel JM, Dunner DL, and Fieve RR: CSF CAMP in primary affective disorder: Effects of probenecid and tryptophan.
82.
Biol. Psychiat
86.
87,
88,
89.
93.
94, Fieve RR, Meltzer 11L, Dunner DL: Ensayo critico con cloruro de rubidio en pacientes deprimidos. Rev. Depart. Psiquatria Facult. Med. Baran, 7:447-452, 1980. 95. Colt EWD, Dunner DL, Hall K, and Fieve RR: A high prevalence of affective disorder in runners, in Psychology of Running, Sacks MH and Sachs ML, eds., Human Kinetics Pub, Inc., Champain, Ill, pp. 234-248, 1981. Dunner DL: Affective Disorders. Current Therapy, Conn HF (ed.), WB Saunders Co., Philadelphia, PA, pp, 956-965, 1981. Goodnick PJ, Fieve RR, Meltzer HL, and Dunner DI,: Lithium elimination half-life and duration of therapy. Clin. Pharm. Therapy. 29:47-60, 1981. Peselow ED, Dunner DL, Fieve RR, and Lautin A: Prophylactic effect of lithium against depression in cyclothymic patients: A life table analysis. Compr. Psychiat, 22:257-264, 1981. Dealy RS, Ishiki DM, Avery DA, Wilson LG, and Dunner DL: Secondary depression in anxiety disorders. Compr. Psychiat. 22:612-618, 1981.
96. 97.
98.
99.
100. Goodnick PJ, Dunner DL, and Fieve RR: Bipolar H - A distinct diagnostic entity? Isr. J. Psychiat. Relat. Sci. 18:221-227, 1981. 101. Bone S, Roose SP, Dunner DL, and Fieve RR: Bioavailability of lithium carbonate: single versus multiple daily dosing. J. Clin. Psychopharm. 1:390-391, 1981. 102, Goodnick RI, Meltzer I-IL, Fieve RR, and Dunner DL: Differences in lithium kinetics between bipolar and unipolar patients. J. Clin. Psychopharm. 2:48-50, 1982. 103. Peselow ED, Gulbenkian G, Dunner DL, Fieve RR, and Deutsch SI: Relationship between plasma lithium levels and prophylaxis against depression in bipolar I, bipolar IL and cyclothymic patients, Compr. Psychiat. 23:176-180, 1982. 104. Dunner DL, Russek RD, Russek B, and Fieve RR: Classification of affective disorder subtypes. Compr. Psychiat. 23:186-189, 1982. 105. Wilson LG, Rosenthal NE, and Dunner DL: The phenomenology of Bipolar I manic depressive illness. J. Canadian Psychiatry 27:150154, 1982.
10
Clinical
115. Avery DH, Wilson LG, and Dunner DL: "Diagnostic subtypes of depression as predictors of therapeutic response," in Treatment of depression: old controversies and new approaches PJ Clayton and JE Barrett (eds.), Raven Press, New York, pp. 193-205, 1983. 116. Dunner DL: Subtypes of bipolar affective disorder with particular regard to bipolar H.
117. Dunner DL: "Drug treatment of the acute manic episode" in Psychiatry Update: The American Psychiatric Association Review, Vol. II, Grinspoon L (ed.), American Psychiatric Press, Inc., Washington D.C., pp. 293-302, 1983. 118. Dunner DL: "Recent genetic studies of bipolar and unipolar depression" in The Affective Disorders, Davis JM and Maas JW (eds), American Psychiatric Press, Inc., Washington, D.C., pp. 183-192, 1983, 119, Dunner DL and Dunner PZ: Psychiatry in China: Some personal observations. Biol. Psychiat. 18:799-801, 1983. 120, Reichler BD, Clement JL, and Dunner DL: Chart review of alcohol problems in adolescent psychiatric patients in an emergency room. J. Clin. Psychiat. 44:330-339, 1983. 121. Rosen LN, Rosenthal NE, VanDusen PH, Dunner DL, and Fieve RR: Age at onset and number of psychotic symptoms in Bipolar I and schizoaffective disorder. Amer. J. Psychiat. 140:1523-1524, 1983. 122. Rosen LN, Rosenthal NE, Dunner DL, and Fieve RR: Social outcome compared in psychotic and non-psychotic bipolar I patients. J. Nerv. Ment. Dis. 171; 272-275, 1983. 123. Dunner DL: "Relationship of Anxiety Disorders to Affective Disorders," Neuropsychiatric Research, E Usdin, M Goldstein, AJ Friedhoff, A Georgotas (eds), pp. 267-274, 1983. 124. Dunner DL: "Affective Disorders" in Current Emergency Therapy, 84, Edlich RF and Spyker DA, eds. Appleton-Century-Crofts, Norwalk, CT, pp. 349-352, 1984. 125. Dunner DL, Shen QJ, Zheng YP, and Dunner PZ: A study of primary affective disorders in the People's Republic of China. Psychiat. 19:353-359, 1984, 126. Myers K and Dunner DL: Acute viral encephalitis complicating a first manic episode. J. Fam. Practice 18:403-407, 1984.
Biol.
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127, Fieve RR, GO R, Dunner DL, and Elston R: Search for biological/genetic markers in a long-term epidemiological and morbid risk study of affective disorders. J. Psychiat, Res. 18:425-445, 1984. 128. Myers KM and Dunner DL: Self and other directed violence on a closed acute-care ward. Psychiatric Quart. 56:178-188, 1984. 129. Dunner DL: "Affective Disorders" in Current Emergency Therapy, 85, Edlich RF and Spyker DA, eds., Aspen Systems Corp., Rockville, MD, pp. 395-398, 1985. Avery DH, Osgood TB, Ishiki DM, Wilson LG, Kenny M, and Dunner DL: The DST in psychiatric outpatients with generalized anxiety disorder, panic disorder, or primary affective disorder. Amer. J. Psychiat 142:844-848, 1985. Dunner DL: "Affective Disorder: Clinical Features" in Psychiatry, Michels R, Cavenar JO Jr., Brodie HKH, Cooper AM, Buze SB, Judd LJ, Klerman GL, and Solnit AI, eds, JB Lippincot Co., Philadelphia, PA Vol I, Ch. 59, pp. 1-13, 1985. Dunner DL: Anxiety and panic: relationship to depression and cardiac disorders. Psychosomatics (Supp1.1 26:18-21, 1985. Sylvester C, Reichler RJ, Hyde TS, and Dunner DL: "Children at risk for panic and anxiety disorder: a preliminary report." In Biological Psychiatry: Clinical and pharmacological studies in psychiatric disorders. Burrows GD, Norman TR, and Dennerstein L: eds. John Libbey, London and Paris, 1985, pp. 115-120. Loebel AD, Hyde TS, Dunner DL: Early placebo response in anxious and depressed patients. J. Clin. Psychiatry, 47:230-233, 1986, Dager SR, Comess KA, and Dunner DL: Differentiation of anxious patients by two-dimensional echocardiographic evaluation of the mitral valve. Amer. J. Psychiatry 143:533-535, 1986. Cowley DS, Dager SR, and Dunner DL: Lactate induced pan e in primary affective disorder. Amer. J. Psychiatry 142:646-648, 1986. Khan A, Lee E, Dager S, Hyde T, Raisys V, Avery D, and Dunner D: Platelet MAO-B activity in anxiety and depression. PSychiatry 21:847-849, 1986.
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Dunner DL, Ishiki D, Avery DH, Wilson LG, and Hyde TS: Effect of alprazolam and diazepam on anxiety and panic attacks in panic disorder: A controlled study. J. Clin. Psychiatry 47:458-460, 1986. Dager SR, Comess KA, Saal AK, and Dunner DL: Mitral valve prolapse in a psychiatric setting: diagnostic assessment, research, and clinical implications. Integative Psychiatry 4:211-223, 1986. Dunner DL: Stability of bipolar H affective disorder as a diagnostic entity. Psychiatric Annals 17:18-20, 1987. Dager SR, Cowley DS, Dunner DL: Biological markers in panic states; lactate induced panic and mitral valve prolapse. Psychiatry 22:339-359, 1987.
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Dager SR, Khan A, Comess KA, Raisys V, and Dunner DL: Mitral valve abnormalities and catecholamine activity in anxious patients. Psychiatry Res. 20:13-18, 1987. Cowley DS, Dager SR, Foster SI, and Dunner DL: Clinical characteristics and response to sodium lactate of patients with infrequent panic attacks. Amer. J. Psychiat. 144:795-798, 1987. Dunner DL, Myers J, Khan A, Avery D, Ishiki D, and Pyke R: Adinazolam, a new antidepressant: Findings of a placebo-controlled, double-blind study in outpatients with major depression. J. Clin Psychopharm, 7:170-172, 1987. Cowley DS, Hyde TS, Dager SR, and Dunner DL: Lactate infusions: the role of baseline anxiety, Psychiatry Res, 21:169-179, 1987. Cohen S, Fligner CL, Raisys VA, Lutni R, and Dunner DL: A case of non-neuroleptic malignant syndrome. J. Clin. Psychiatry, 48:287-288, 1987. Dager SR, Holland JP, Cowley DS, and Dunner DL: Panic disorder precipitated by exposure to organic solvents in the work place.
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Meibach RC, Dunner DL, Wilson LG, Ishiki D, and Dager SR Comparative efficacy of propranolol, chlordiazepoxide, and placebo in the treatment of anxiety: a double-blind trial. J. Clin. Psychiatry, 48:355-358, 1987. Dunner DL and Clayton PJ: "Drug treatment of bipolar disorder." In Psychopharmacology: The Third Generation of Progess, Meltzer HY, ed., New York, Raven Press, 1987, pp. 1077-1083. Cowley DS, Dager SR, and Danner DL: Lactate infusion in major depression without panic attacks. J. Psychiat Res., 21:243-248, 1987, Cohen S, Khan A, Clark A, Goldner M, and Dunner DL: Hospitalization effect in acute mania. Gen. Hosp. Psychiatry, 10:1-4, 1988. Dunner DL: "High risk studies: the impact of research design on research results." In Relatives at Risk for Mental Disorder, Dunner DL, Gershon ES, and Barrett JE, eds, New York, Raven Press, pp. 65-71, 1988. Danner DL: "The phenomenology of mania." In Perspectives in Psychopharmacology, Barchas JD and Bunney WE Jr., eds, Alan R. Liss, Inc., New York, pp, 475-482, 1988. Dager SR, Saal AK, Commes DA, and Dunner DL: Mitral valve prolapse and the anxiety disorders, Hosp. and Comm. Psych, 39:517527, 1988. Cowley DS, Dager SR, McClellan J, Roy-Byrne PP, and Dunner DL: Response to lactate infusion in generalized anxiety disorder, Biol Psychiatry, 24:409-414, 1988. Khan A, Johnsen F, Avery DH, Cohen S, Scherzo B, and Danner DL: DST results in non-psychotic depressed outpatients, Amer. J. Psychiat. 145:1153-1156, 1988. Danner DL: "Mania" in Handbook of Clinical Psychopharmacology, Trupin JP, Shader RI, and Harnett DS, eds., Jasen Aronsen Inc., Northvale, NJ, pp. 97-109, 1988. Cowley DS and Dunner DL: Response to sodium lactate in panic disorder: relationship to presenting clinical variables, Psychiatry Research, 25:253-259, 1988. Dager SR, Roy-Byrne PP, and Danner DL: "Stress, anxiety and the cardiovascular system," in Handbook of Anxiety (Vol. 2), Noyes R, Roth M, and Burrows GD, eds., Elsevier, pp. 399-429, 1988. Dager SR, Holland JP, Cowley DS, and Danner DL: Panic attacks and exposure to chemical agents (letter). Amer. J. Psychiat. 145:532-533, 1988. Danner DL: "Affective disorders," in Conn's Current Therapy, Rakel RE, ed., WB Saunders Co., Philadelphia, PA, pp. 994-1002, 1989. Dager SR, Cowley DS, Dorsa DM, and Dunner DL: Plasma beta-endorphin response to lactate infusion, Biol. Psychiatry, 25:245245, 1989, Khan A, Cohen S, Dager S, Avery DH, and Danner DL: Onset of response in relation to outcome in depressed outpatients with placebo and imipramine, J A ffective Disorders, 17:33-38, 1989, Cowley DS, Dager SR and Danner DL: Lactate response in patients with primary major depression (letter). 27:357-358, 1989.
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Roy-Byrne PP, Dager SR, Cowley DS, Vitaliano P, and Danner DL: Relapse and rebound following discontinuation of benzodiazepine treatment of panic attacks: Alprazolam versus diazepam. Amer. J. Psychiat. 146:860-865, 1989.
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Avery DH, Khan A, Dager SR, Cohen S, Cox GB, and Dunner DL: Morning or evening bright light treatment of winter depression? The significance of hypersomnia. Biol Psychiatry 29:117-126, 1991. Cowley DS, and Dunner DL: "Benzodiazepines in anxiety and depression" in Benzodiazepines in Clinical Practice: Risks and Benefits. Roy-Byrne, PP and Cowley DS, Eds., American Psychiatric Press, Inc., Washington, D.C., pp 37-56, 1991. Khan A, Dager SR, Cohen S, Avery DH, Scherzo B, and Dunner DL: Chronicity of depressive episode in relation to antidepressantplacebo response. Neuropsychopharmacology 4:125-130, 1991. Ward N; Whitney C, Avery D, and Dunner DL: The analgesic effects of caffeine in headache. Pain 44:151-115, 1991. Dunner DL: Depression: Challenges for the future. J Clin Psychiatry 52:5 (Suppl): 44-51, 1991. Cowley DS, Dager SR, Roy-Byrne PP, Avery DH, and Dunner, DL: Lactate vulnerability after alprazolam versus placebo treatment of panic disorder. Biol Psychiatry 30:49-56, 1991. Dunner DL: Differential diagnosis of bipolar disorder. J Clin Psychopharmacology 12: 75-125, 1992. Dunner DL and Dunbar GC: Optimal dose regimen for paroxetine. J Clin Psychiatry 53: 2 (Suppl) 21-26, 1992. Dunner DL, Cohn JB, Walshe T III, Cohn CK, Feighner JP, Fieve RR, Halikas JP, Hearst ED, Settle EC Jr, Menolascino H, Muller DJ: Two combined, multicenter double-blind studies of paroxetine and doxepin in geriatric patients with major depression. J Clin Psychiatry 53:2 (Suppl) 57-60, 1992. Roy-Byrne PP, Vitaliano PP, Cowley DS, Luciano G, Zheng YP, and Dunner DL: Coping in panic and major depressive disorder: Relative effects of symptom severity and diagnostic comorbidity. J Nerv Ment Dis 180: 179-183, 1992,
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Dager SR, Loebel JP, Claypool K, Case M, Budech CB, and Dunner DL: Oxiracetam in the treatment of primary dementia of the Alzheimer's type: A small case series. Int J Geriatric Psychiatry 7:905-912, 1992. Dunner DL: Diagnostic and treatment considerations in the depressed elderly patient. Advances in Therapy 9:350-359, 1992. Dager SR, Roy-Byrne P, Hendrickson H, Cowley DS, Avery DH, Hall KC and Dunner DL: Long-term outcome of panic states during double-blind treatment and after withdrawal of alprazolam and placebo Annals of Clin Psychiatry 4: 251-258, 1992. Dumier DL: ""Diagnostic and treatment considerations for the depressed elderly patient" in Serotonin: Reshaping the treatment of depression, Medicine Publishing Foundation, Symposium Series 32. Toronto, The Medicine Group (Canada) LTD, pp. 43-52, 1992. Avery DH, Bolte MA, Dager SR, Wilson LG, Weyer M, Cox GB and Dunner DL: Dawn simulation treatment of winter depression: A controlled study. Amer J Psychiatry 150:113-117, 1993. limner DL: Diagnosing and treating bipolar II disorder. Directions in Psychiatry 13:1-8, 1993. Flick SM, Roy-Byrne PP, Cowley DS, Shores M1V1 and Dunner DL: DSM-III-R personality disorders in a mood and anxiety disorders clinic: Prevalence, comorbidity, and clinical correlates. J Affective Disorders 27:71-79, 1993. Dunner DL: A review of the diagnostic status of "Bipolar II" for the DSM-IV work group on mood disorders. Depression 1:2-10, 1993. Bauer MS and Dunner DL: Validity of seasonal pattern as a modifier for recurrent mood disorders for DSM-IV. Compr Psychiatry 34:159-170, 1993. Wingerson D, Sullivan M, Dager S, Flick S, Dunner D, and Roy-Byrne P: Personality traits and early discontinuation from clinical trials in anxious patients. J Clin Psychopharmacology 13:194-197, 1993. Dunner DL: Diagnostic Assessment. Psychiatric Clinics of North America 16: 431-441, 1993. Nelsen MA and Dunner DL: Treatment resistance in unipolar depression and other disorders. Psychiatric Clinics of North America. 16:541-566, 1993. Wu LH and Dunner DL: Suicide attempts in rapid cycling bipolar patients. J Affective Disorders 29:57-61, 1993. Dunner DL and Tay LK: Diagnostic reliability of the history of hypomania in bipolar II patients and patients with major depression. Compr Psychiatry 34:303-307, 1993. Dunner DL: Managing the patient with depression and anxiety. Eur Psychiatry 8 (Suppl): 95-125, 1993. Bauer MS, Calabrese J, Dunner DL, Post R. Whybrow PC, Gyulail L, Tay LK, Younkin SR, Bynum D, Lavori P, and Price RA: Multisite data reanalysis of the validity of rapid cycling as a course modifier for bipolar disorder in DSM-IV. Amer J Psychiatry 151:506-515, 1994. Dunner DL: An overview of paroxetine in the elderly. Gerontology 40 (Suppl):21-27, 1994. Dunner DL: Commentary on "Placebo as a treatment for depression." Neuroppsychopharrnacology10:273-274, 1994. Heiligenstein JR, Faries DE, Rush AJ, Andersen JS, Pande AC, Roffwarg HP, Dunner DL, Gillin JC, Lahmeyer H, Zajecka J, Tollefson GD and Gardner DM: Response patterns in depressed outpatients with and without melancholia: A double blind placebocontrolled trial of fluoxetine versus placebo. J Affective Disorders 30:163-173, 1994.
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Dunner DL. Improving the quality of cwe of depressed patients with co-morbid psychiatric disorder: A review. Clinical
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Dunner DL. Lithium carbonate: Maintenance studies and consequences of withdraval. J Clin Psychiatry59 (Suppl 6):48-55, 1998. Dunner DL. An evaluation of phannaceutical agents after their release for prescriptive use.
Dunner DL. Kumar R. Paroxetine: a review of clinical experience. Pharmacopsychiat 31:89-101, 1998. Dunner DL, Zisook S, Billow AA, Batey, SR, Johnston JA, Ascher JA. A prospective safety surveillance study for bupropion sustained-release in the treatment of depression. J Clin Psychiatry 59:366-373, 1998. Dunner DL. Treatment of dysthymic disorder, Depression and Anxiety 8, Suppl 1:54-58, 1998. Fava M, Amsterdam JD, Deltito JA, Salzman C. Schwaller M, Dunner DL. A double-blind study of paroxetine, fluoxetine, and placebo in outpatients with major depression. Annals of Clin Psychiatry10: 145-150, 1998, Dunner DL. "Rapid-cycling bipolar affective disorder" in JF Goldberg and M Hairow eds Bipolar Disorders Clinical Course and Outcome, Washington DC, American Psychiatric Press, Inc, pp. 199-217, 1999. Dunner DL. Long-term use of sedative and hypnotic medication. Arch Gen Psychiatry 56:335, 1999 (Commentary) Avery DH, Claypoole K, Robinson L, Neumaier J, Dunner DL, Scheele L, Wilson L, Roy-Byrne P. Repetitive transcranial magnetic stimulation in treatment of medication-resistant depression. Preliminary data. J Nerv Ment Dis 187:114-117, 1999, Dunner DL. "A two-illness model of bipolar disorder' by RT Jaffe, LT Young, and GM MacQueen: a comirentary. Disorders 1:3637, 1999. Dunner DL, Hendrickson HE, Bea C, Budech CB, O'Connor E. Dysthymic disorder: Treatment with mirtazapine. and Anxiety 10:68-72, 1999
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Comtois KA, Cowley DS, Dunner DL, Roy-Byrne PP. Relationship between borderline personality disorder and ais I diagnosis in severity of depression. J. Clin Psychiatry 60:752-758, 1999. Dunner DL, Duration of euthymia in dysthyrnic patients. Amer J Psychiatry 156:1992-1993, 1999. Dunner DL, Neumaier JF. "Lithium use in clinical practice" in EE Bittar and N Bittar, eds. Biological Psychiatry, JAI press, Stamford CT, pp 569-583, 2000.
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Sanger TM, Tohen M, Vieta E, Dunner DL, Bowden CL, Calabrese JR, Feldman PD,Jaeobs TG, Breier A Olanzapine in the acute treatment of bipolar I disorder with a history of rapid cycling. J Affect Disorder 73:155-161, 2003 Dunner DL. Current therapeutic approaches for dysthymic disorder. Expert Rev. Neurotterapeutics 3:119-125, 2003. Manber R, Rush A, Thase ME, Arnow B, Klein D, Trivedi MH, Korenstein SG, Markowitz JC, Dunner DL, Munsaka M, Borian FE, Keller M: The effects of psychotherapy, nefazodorr, and their combination on subjective assessment of distubed sleep in chronic depression. Sleep, 2003; 15:130-138, Dunner DL. Drug interactions of lithium and other antimanic/mcod-stabilizing medications. J Clin Psychiatry 64: supp 5, 3843,2003. Rapaport MH, Schneider LS, Donner DL, Davies JT, Pitts CD. Efficacy of controlled-relase paroxetine in the treatment of latelife depression. J Clin Psychiatry 64:1065-1074, 2003. Dunner DL, Goldstein DJ, Mallincrodt C, Lu Y, Detke Ml, Duloxetine in treatment of anxiety Fmptoms associated with depression. Depress & Anxiety 18; 53-61, 2003. Gelenberg AJ, Trivedi MB, Rush AJ, Thara MG, Howland R, Klein DN, Kornstein SG, thinner DL, Marlowitz JC, Hirschfeld R1VIA, Keitner GI, Zajecka J, Kocsis JH, Russell JM, Miller I, Manber R, Arnau B, Rothbaum B, Munsaka M, Banks P, Borian FE, Keller MB. Randomized, placebo-controlled trial of nefazodone maintenance treatment in preventing recurrence in chronic depression. Biol Psychiatry 54:8056-817, 2003. Dunner DL., Anxiety and depression in the elde47: Implications for diagnosis and treatment, CNS Spectrums 8: 5, 2003. Dunner DL., Treatment consideratbns for depression in the elderly. &IS Spectrums, 8:14-19, 2003. Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schlzberg AF, Ninan PT, McCullough JP, Jr., Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma, Proc NitI Acad Sci USA 100:14293-14296, 2003. Dunner DL. Clinical consequences of under-recognized bipolar spectrum disorder. Bipolar Disorders 5:456-463, 2003, Dunner DL. Multiple perspectives on bipolar disorder. CNS Spectrums 8:890, 2003. Vo D, Dunner DL. Treatment resistant bipolar disorder: a comparison of rapid cyclers and non-rapid cyclers. CNS Spectrums 8:948-952, 2003. Chun BJDH, Dunner DL. A review of antidepressant-induced hypoman a in major depression; suggestions for DSM-V. Bipolar Disorders. 6:32-42, 2004. Lyoo IK, Kim MJ, Stoll AL, Demopulos CM, Parow AM, Dager SR, Friedman SD, Dunner DL, Renshaw PF, Frontal Lobe matter density decreases in bipolar I disorder. Biol Psychiatry 55:648-651, 2004, Dunner DL. Paroxetine controlled release: a viewpoint by David L. Dinner. CNS Drugs 18; 6:365-366, 2004. Dager SR, Friedman SD, Parow A, Demopulox C, Stoll AL, Lyoo IK, Dunner DL, Renshaw PF. Brain metabolic alternations in medication-free patients with bipolar disorder. Arch Gen Psychiatry 61:450-458, 2004. Kocsis JH, Rush AJ, Markowitz JC, Borian FE, Dunner DL, Koran CM, Klein DN, Trivedi MH, Arnow B,Keitner G, Kornstein SG, Keller MB, Continuation treatment of chronic depression: a comparison of nefazodone, cognitivie behavioral analysis system of psychotherapy, and their combination.Psychopharm Bull; 37:73-87, 2003.
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Dunner DL. Correlates of suicidal behavior and lithium treatment in bipolar disorder. J Clin Psychiatry 65(Suppl 10): 5-10,2004.
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Dunner DL. Treatment-resistant depression: an overview of the problem. Prim Psychiatry 12:27-29, 2005. Dunner DL. Atypical antipsychotics: efficacy across bipolar disorder subpopulations. J Clin Psychiatry 66:20-26, supp 3, 2005. Dunner DL. Double depression. CNS Spectrums 10174, 2005. Dunner DL. Hypomania. Depression: Mind and Body 1; 114-117, 2005, Dunner DL. Dysthymia and double depression. Int Re/ Psychiatry 17:3-8, 2005. Dunner DL, D'Souza DN, Kajdasz DK, Detke MJ, Russell JM. Is treatment-associated hypomania rare with duloxetine: Secondary analysis of controlled trials in non-bipolar depression.. J Affective Disorders 87: 115-119, 2005. Dunner DL. The role of pain in stress and anxiety. Primary Psychiatry 128-11, 2005. Dunner DL. Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Bipolar disord. 7; 307-325, 2005. George MS, Rush AJ, Marangell LB, Sackeim HA, Brannan SK, Davis SM, Howland R, Kling MA, Moreno F, Rittberg B, Dunner DL, Schwartz T, Carpenter L, Burke M, Ninan P, Goodnick P. A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression. Biol Psychiatry 2005;58:364-73. Avery DH, Holtzheimer III PE, Fawaz W, Russo J, Neumaier J, Dunner DL, Haynor DR, Claypcole KH, Wajdik C, Roy-Byrne P. A controlled study of repetitive tranTranial magnetic stimulation inmedication-resistant major depression. Biol Psychiatry. 2006; 59:187-194. Dunner DL. Bipolar depression.CNS Spectr. 2005; 10:528. Dunner DL. First episode: depression and panic disorder. CNS Spectr. 2005; 10:696-7. Dunner DL .Depression, dementia or pseudodementia? CNS Spectr. 2005; 10:862 Dunner DL., Wohlreich MM, Mallinckrodt CH, Watkin JG, Fava M. Clinical consequences of inithl duloxetine dosing strategies: comparison of 30 and 60 mg starting doses. Curr Therepeutic Res 2005; 66:522-540. Dunner DL. "Lithium" in JK Aronson, Side Effects ofDrugs Annual 28. Elsevier: Amsterdam: 2005, pp 23-27. Dunner DL. First onset of schizophrenia. CNS Spectr 2006; 11:19. Lyoo IK, Sung YH, Dager SR, Friedman SD, Lee JY, Kim SJ, Kim N, Dunner DL, Renshaw PF. Regional cerebral cortical thinning in bipolar disorder. Bipolar Disord 2006; 8:65-74.
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Amsterdam JD, et al. Antidepressant tachyphylaxis after repeated drug exposures in patients with recurrent major depression. Bader C, Dunner DL Bipolar spectrum* Canuso CM, Bossie CA, Zhu Y, Youssef E, Dunner DL. Identification and treatment of psychotic symptcms in patients with bipolar mania. Bauer M, Beaulieu S, Dunner DL, Lafer B, Kupka R. Rapid cycling bipolar disorderDiagnostic concepts. Dimidjian S et al Jacobson 2 Dimidjian S et al Jacobson 3 (allegiance) Dunner DL et al, Dulox extension* Dunner D Depression: Issues related to predicting treatment response (guest editor forward forPrimary Psychiatry)* Dunner DL, Winokur chapter rewrite*
Keller MB et alPREVENT ACUTE* Komstein S, Dunner D, Meyers A, Whitmyer V, Mallinckrodt C, Wohlreich M, Detke M, Hollandbeck M, Greist J, A randomized, doubleblind study of increasing or maintaning duloxetine dose in patients without remission of major depressive disorder afterinitial duloxetine therapy. Lyoo IK et al. Lithium and valproic acid treatment effects on brain gray matter volume in bipolar disorder : a longitudinal follow-up brain imaging study Reirnherr FW et al. Genetic Polymorphisms in the treatment of depression: Speculations from an augmentation study using atomoxetine Whitmyer VG, Dunner Dl, Kornstein SG, Meyers AL, Mallincrodt CH, Wohlreich MM, Gonzales JS, Greist JH. A comparison of initial duloxetine dosing strategies in patients with major depressive disorder
BOOKS 1. 2. 3, 4. Dunner DL, Gershon ES and Barrett JE (eds). Relatives at risk for mental disorder. Raven Press, New York, NY, 1988. Dunner DL, ed. Current Psychiatric Therapy. W.B. Saunders, Philadelphia, PA, 1993. Dunner DL: Guest Editor, Psychopharmacology I. The Psychiatric Clinics of North America, W.B. Saunders, Philadelphia, 1993. Dunner DL, Guest Editor Psychophannacology II. The Psychiatric Clinics of North America, W.B. Saunders, Philadelphia, PA, 1993. Dunner DL, ed. Cun-ent Psychiatric Therapy II. W.B. Saunders, Philadelphia, PA, 1997, Dunner DL, Rosenbaum JF, eds. The Psychiatric Clinics of North America Annual of Drug Therapy 1997. W. B. Saunders, Philadelphia, PA, 1997. Dunner DL, Rosenbaum JF, eds. The Psychiatric Clinics of North America Annual of Drug Therapy 1998. W. B. Saunders, Philadelphia, PA, 1998.
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Durmer DL, Rosenbaum JF, eds. The Psychiatric Clinics of North America Annual of Drug Therapy 1999. W.B. Saunders, Philadelphia, PA, 1999. Dunner DL, Rosenbaum JF, eds. The Psychiatric Clinics of North America Annual of Drug Therapy 2000. W.B. Saunders, Philadelphia, PA. 2000, Dunner DL, Rosenbaum JF, eds. The Psychiatric Clinics of North America Annual of Drug Therapy 2001. W.B Saunders, Philadelphia, PA,. 2001. Rosenbaum JF, Dunner DL, eds, Drug Therapy: Predictors of Response. The Psychiatric Clinics of North America, vol 26: no.2, WB Saunders, Philadelphia PA, June 2003. Section Editor, "Psychopharmacological Treatment." Schatzberg AF and Nemeroff CB, eds. The American Psychiatric Publishing Textbook of Psychophatmacology, Third Edition, American Psychiatric Publishing, Washington, D.C., 2003.
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OTHER EDITORIAL EFFORTS: 1. 2. Guest Editor, Treatment Resistant Depression, Primary Psychiatry Vol 12, No 2: Feb 2005. Columnist, Interactive Case Conference, CNS Spectrums. Double Depression 10 174, 2005; Depression in the Elderly 10: 354, 2005; First Episode: Depression and Panic Disorder 10; 696-697, 2005. Depression, dementia or psudo dementia? 10:862, 2005; first onset of schizophrenia; 19,2006.
PRESENTATIONS AND ABSTRACTS Dunner DL, Gershon ES, and Gcodwin FK: Heritable factors in the severity of affective illness. Presented at the Annual Meeting, American Psychiatric Association, San Francisco May 1970. (Sc. Proc. Amer. Psychiat. Assn., 123:187-188, 1970) 2. Goodwin FK, Dunner DL, and Axelrod J: Rapid elevation of biogenic aminemetabolites in human CSF following probenecid. Presented at the Fourth Annual Winter Cmference on Brain Research Snow Mass-at-Aspen, Colorado, January 1971. (Abstracted by Brain Information Service) Goodwin FK, Murphy DL, Dunner DL, and Bunney WE Jr.: Lithium response in unipolar vs lipolar depression. Presented at the Annual Meeting, American Psychiatric Association, Washington, D.C., May 1971. (Sc. Proc. Amer. Psychiat. Assn., 124:110111, 1971) Gershon ES, Dunner DL, Stuart L, and Goodwin FK: Assortative mating in the affective disorders; a preliminary report. Presented at the Annual Meeting, Ancrican Psychiatric Association, Washington DC, May 1971, (Sci. Proc. Amer. Psychiat Assn. 124: 209-210, 1971) Goodwin FK, Post RM, Dunner DL, and Bunney WE Jr.: CNS amines and affective illness. Probenecid studies. Presented at the Annual Meeting, American Psychiatric Association, Dallas, Texas, May, 1972. (Sci. Proc. Amer. Psychiat Assn., 125:47-48, 1972) Fieve RR, Meltzer HL, Levitt M, and Dunner DL: Rubidium: Biochemical, behavioral and metabolic studies in humans. Presented at the Annual Meeting, Ancrican Psychiatric Association, Dallas, Texas, May 1972. Bunney WE Jr., Dunner DL, Fieve RR, Katz MM, Mendlewicz J, Winokur G: Manic Depressive Illness. Council for Interdisciplinary Communication in Medicine, Ltd. (Audio tape) 1972, Dunner DL: The Treatment of Tomorrow's Depression. Panel Discussion at the 10th Western Divisional Meeting, American Psychiatric Association, San Diego, CA. October 1972, (Audio-Digest Foundation 1 No. 10) (Psychiatry-Audio tape.) Dunner DL: Psychotropic Drugs in Clinical Practice. Presented at the 167th Annual Convention of the Medical Society of the State of New York, New York, NY, February 1973. (New York State J. of Med. 74:376-377, 1974.) Dunner DL: Clinical Characteristics of Lithium Prophylaxis Failures. Presented at the 18th Annual Conference, VA Studies in Mental Health and Behavioral Sciences, New Orleans, LA, March 1973. (Highlights of the 18th Annual Conference, pp. 67-69, 1973).
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Perel J, Levitt M, and Dunner DL: Plasma and cerebrospinal fluid probenecid concentrations related to accumulation of acidic biogenic amine metabolites in man, Presented to FASEB, Atlantic City, NJ, April 1973. (Fed. Proc. 32:696, 1973.) Dunner DL, Meltzer HL, and Fieve RR: CSF Rubidium metabolism in depression. Presented at the annual meeting, Amer. Psychiatric Assn., Honolulu, Hawaii, May 1973. (Sci. Proc. Amer. Psychiat Assn.), 126:190-191, 1973. Dunner DL: Lithium carbonate in the treatment of mood disorders. Presented to Brooklyn District Branch, Amer. Psych. Assoc, Brooklyn, NY, November 1973. Dunner DL: Amine precursors in depression: Studies combining liclopa and L-tryptophan. Presented at the 12th annual meeting, American College of Neuropsychcpharmacology, Palm Springs, CA, December 1973. Abstracted in Psychopharmacology Bulletin, 10:56-57, 1974. Dunner DL: Recent research on classification, genetics, and treatment of depression. Presented to the New York Society of Clinical Psychologist, Inc., New York, May 1974, Dunner DL and Fieve RR: Affective disorders: studies with amine precursors. Presented at the annual meeting, Amer. Psychiat. Assoc., Detroit, Michigan, May 1974. (Sci. Proc. Amer. Psychiat. Assn.), 127:160, 1974). Dunner DL: Treating affective states with lithium. Medical World News Review, Psychiatry Issue, 129-30, 1974. Dunner DL, Fleiss JL, and Fieve RR: Lithium carbonate prophylaxis failure. Presented at the annual meeting, Amer. Psychiat. Assn., Anaheim, CA, May 1975. (Sci. Proc. Amer. Psychiat. Assn, 128:215-216, 1975) Fieve RR, Dunner DL, Stallone F, Kumbaraci T, and Fleiss JL: Lithium prophylaxis of three depression ath-types. Presented at the annual meeting, American Psychiatric Assn., Anaheim, CA, May 1975. (Sci. Proc. Amer, Psychiatry. Assn. 128:216-217, 1975) Farkas T, Dunner DL, and Fieve RR: L-tryptophan in depression. Presented at the 30th annual meeting, Society of Biological Psychiatry, New York, May 1975, Diamond S, Rubenstein A, Dunner DL, and Fieve RR: Menstrual problems in women with primary affective illness. Presented at the 30th annual meeting, Society of Biological Psychiatry, New York, May 1975. Duimer DL and Fieve RR: The lithium ion: its impact on diagnostic practice. Presented at 'Biological Predictors in PsychiatricDisorders" (International symposium sponsored by the University of Tennessee Center for the Health Sciences), Memphis, Tennessee, December 1975. Dunner DL, Patrick V, and Fieve RR: Rapid cycling manic depresdve patients. Presented at the annual meeting, American Psychiatric Assn., Miami, Florida, May 1976. (Sci. Proc. Amer. Psychiat. Assn. 129:299-300, 1976) Dunner DL: Affective illness and the family (Panel). Presented at the annual meeting, American Psychiatric Assn., Miami, Florida, May 1976. (Sci Proc Amer Psychiat Assn, 129:339-340, 1976) Dempsey GM, Dunner DL, Meltzer HL, and Fieve RR: Lithium toxicity. Presented at the First International Symposium on Neurotoxicology, New York, May 1976) Dunner DL, Levitt M, Kumbaraci T, and Fieve RR: Erythrocyte catechol-o-methyltransferase activity in primary affective disorder. Presented at the annual meeting, Soci4 of Biological Psychiatry, San Francisco, CA, June 1976. (Abstracts, p. 60) Dunner DL and Fieve RR: The effect of lithium in depressive sub-types. Presented at the 10th Congress, Collegium Internationale Neuropsychopharmacologicum, Qtebec, Canada, July 1976. (Abstracts, p. 25) Fieve RR, Meltzer HL, Kumbamci TE, and Dunner DL: Multiple enzyme profiles as possible biochemical markers tests for affective disorders. Presented at the 10th Congress, Collegium Internationale Neuropsychopharmacologitm, Quebec, Canada, July 1976. (Abstracts, p. 221)
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Fieve RR, Peselow ED, and Dinner DL: The long-term efficacy of tricyclic antidepressants. Presented at the 138th Annual Meeting, American Psychiatric Association, Dallas, Texas, May 18-24, 1985 (Abstracts p.192). Dunner DL: Cardiovascular aspects of generalized anxiety disorder. Resented at the 138th Annual Meeting, American Psychiatric Association, Dallas, Texas, May 18-24, 1984, Khan A, Lee E, Hyde T, Dager S, Avery D, and Dunner DL: Platelet monamine oxidase activity in depression and anxiety. Presented at the IV World Congress of Biological Psychiatry, September 8-13, 1985, Philadelphia, Pennsylvania (Abstracts p.90). Cowley DS, Dager SR, and Dunner DL: Lactate-induced panic in primary depression. Presented at IV World Congress of Biological Psychiatry, September 8-13, 1985, Philadelphia, PA. (Abstracts p.213) Dunner DL: A Study Group: "Conceptual and methodological uncertainties in the biological provocation of panic attacks." Presented at the Annual Meeting, Anerican College of Neuropsychoplarmacology, Maui, Hawaii, December 9-13, 1985. Lewy AJ, Sack RL, and Dunner DL: Three critical parameters for chronobiologically active light: intensity, wave length, and timing. Presented at the Annual Meeting, American College of Neurcpsychopharmacology, Maui, Hawaii, December 9-13, 1985 (Abstracts p,117). Reichler RJ, Hyde T, Sylvester C, and Dunner DL: Children at risk for anxiety disorders and depression. Presented at the Annual Meeting, American College of Neuropsychopharmacolow, Maui, Hawaii, December 9-13, 1985 (Abstracts p.134). Dager SR, Khan A, Comess K, Raisys V, and Dunner D: Catecholamine activity, autonomic arousal and mitral valve prolapse in anxious patients. Presented at the 41st Annual Meeting, Society of Biological Psychiatry, Washington, DC, May 7-11, 1986 (Abstracts p.106). Cowley DS, Dager SR, and Dunner DL: Lactate-induced panic: effects of alprazolam treatment. Presented at the 41st Annual Meeting, Society of Biological Psychiatry, Washington, DC, May 7-11, 1986 (Abstracts p.131). Dunner DL: Stability of bipolar II affective disorder. Presented a the 139th Annual Meeting of the Anerican Psychiatric Association, May 10-16, 1986, Washington, DC (Abstracts p.162). Cowley DS, Hyde TS, Dager SR, and Dunner DL: Lactate infusions: the role of baseline anxiety. Presented at the 139th Annual Meeting, American Psychiatric Association, May 10-16, 1985, Washington DC (New Research Abstract, p.23). Cowley DS, Dager SR, and Dunner DL: Lactate infusions in different diagnostic groups. Presented at the 15th meeting of the Collegium Internationale Neuropsychopharmacologicum, San Juan, Puerto Rico, December 1417, 1987, Khan A, Cohen S, Chiles J, Hyde T, and Dunner DL: Therapeutic roleof a psychiatic intensive care unit in acute psychosis. Presented at the 42nd Annual Meeting, Society of Biological Psychiatry, Chicago, IL, May 6-10, 1987 (Abstracts, p.37), Dager SR, Cowley DS, Dorsa DM, and Dunner DL: Beta-endorphin response to hctate infusion. Presented at the 42nd Annual Meeting, Society of Biological Psychiatry, Chicago, IL, May 6-10, 1987 (Abstracts, p.I90). Khan A, Cohen S, Avery DH, and Dunner DL: Treatment options in psychotic depression. Presented at the 42nd Annual Meeting, Society of Biological Psychiatry, Chicago, IL, May 6-10, 1987 (Abstracts, p.301). Khan A, Hyde T, and Dunner DL: Treatment response to plwebo and IMI/DMI in outpatients with major depression. Presented at the 42nd Annual Meeting, Societi of Biological Psychiatry, Chicago, IL, May 6-10, 1987 (Abstract s, p.302). Dager SR, Cowley DS, Kenny M, and Dunner DI,: NE response to lactate infusion in panic, depressed and control subjects. Presented at the 6th International Catecholamine Symposium, Jerusalem, Israel, June 14-19, 1987 (Abstracts, p.117). Dager SR, Cowley DS, Kenny M, and Dunner DL: NE levels in panic patients differentiated by response lo lactate infusion. Presented at the 6th International Catecholamine Symposium, Jerusalem, Israel, June 14-19, 1987 (Abstracts, p.188). Dunner DL, Avery DH, Dager SR, and Khan A: Rolipram; A placebo-controlled Mal in outpatients with major depressive disorder, Presented at the 6th Inteinational Catecholamine Symposium, Jerusalem, Israel, June 14-19, 1987 (Abstract s, p.119).
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Dunner DL: The diagnosis and netrobiology of anxiety disorders. Presented at the Ninth World Congress of the International College of Psychosomatic Medicine, Sydney, Australia, August 30-September 4, 1987 (Abstracts, p.47). Khan A and Dunner DL: Clinical predictors of placebo response in depressed outpatients. Presented at the 26th Annual Meeting, American College of Neuropsychcpharmacology, San Juan, Puerto Rico, December 7-11, 1987 (Abstracts, p.58). Dager SR, Rainey JM, Danner DL, Artru A, Kenny M, and Bowden D: Central effects of lactate infusion in a primate model. Presented at the 26th Annual Meeting, American College of Neuropsychopharmacology, San Juan, Puerto Rico, December 711, 1987 (Abstracts, p.58). Reichler RJ, McClellan J, and Dunner DL: Affective disorders presetting as attention deficit disorders in childhood. Presented at the 26th Annual Meeting, Americm College of Neuropsychopharmacology, San Juan, Puerto Rico, December 7-11, 1987 (Abstracts, p.184). Ward N, Whitney C, Avery D, and Dunner D: Caffeine's effects on mood and pain. Presented at the 43rd Annual Meeting, Society of Biological Psychiatry, Montreal, Canada., May 4-8, 1988. Abstracts p.68. Ward N, Labbe RF, and Dunner D: Pyridoxim and iron states in depression. Presented at the 43rd Annual Meeting, Society of Biological Psychiatry, Montreal, Canada, May 4-8, 1988. Abstracts p.301. Dunner DL, Avery DH, Dager SR, and Khan A: Rolipram: a placebo-controlled trial in outpatients with major depressive disorder. Presented at the XVI CINP Congress, Munich, August 15-19, 1988. Abstracts p.245. Khan A, Dager S, and Dunner DL: Clinicd and demographic features related to placebo and antidepreant response. Presented at the 44th Annual Meeting, Society of Biological Psychiatry, San Francisco, CA, May 4-8, 1989. Abstracts, pp.79A-80A. Avery D, Khan A, Dager SR, Cox GB, and Dunner DL: Bright light treatment of winter depression: AM compared to PM light. Presented at the 44th Annual Meeting, Society of Biological Psychiatry, San Francisco, CA, May 4-8, 1989. Abstracts, p. 83A. Dunner DL: Diagnosis and treatment of seasonal depression. Presented at the 142nd Annual Meeting, American Psychiatric Association, San Francisco, CA, May 6-11, 1989. Abstracts p.42. Dunner DL, Colombo M, and Cox G: Assortative mating in affective disorders: an update. Presented at the First World Congress on Psychiatric Genetics, Cambridge, England, August 3-5, 1989 (Abstracts, p.5). Dager SR, Khan A, Cowley DC, Avery D, Elder J, Roy-Byrne P, and Dunner DL: Clinical characteristics of placebo response among panic patients. Presented at the 28th Annual Meeting, Americm College of Neuropsychopharmacology, Maui, HI, Dec. 10-15, 1989. (Abstracts P.183). Khan A, Dager S, Cohen S, Avery DH, and Dunner DL: When is the onset of response to antidepressants? Presented at the 28th Annual Meeting, American College of Neuropsychopharmacology, Maui, HI, Dec. 10-15, 1989. (Abstracts P. 198). Peselow ED, Dunner DL, and Fieve RR: The prophylactic effect of tricyclic antidepressants - a five year follow-up. Presented at the 28th Annual Meeting, American College of Neuropsychopharmacology, Maui, HI, 1989. Dec. 10-15, 1989. (Abstracts p.212). Brown WA and Dunner DL (Co-Chairs): Placebo response in depression. Study Group - Presented at the 28th Annual Meeting, American College of Neuropsychcpharmacology, Maui, HI, Dec. 10 -15, 1989. (Abstracts P.44). Dunner DL, Colombo M, Cox G: Assortative mating in mood and anxiety disorders. Presented at the 17th Congress of Collegium Internationale Neuro-Psychopharmacologicum, Kyoto, Japan, Sept. 10-14, 1990. (Abstracts P.58). Dager SR, Comess KA, Saal AK, Sisk EJ, Cowley DS, Avery DH and Dunner DL: Mitral valve prolapse and panic disorder; Clinical and biological characteristics. Presented at the 29th Annual Meeting, American College of Neuropsychopharmacology, San Juan, PR, Dec. 10-14, 1990. (Abstracts P. 124). Dunner DL, Colombo M, Cox G: Assortative mating in mood and anxiety disorders. Presented at the 46th Annual Meeting, Society of Biological Psychiatry, New Orleans, LA, May 5-12, 1991. (Abstracts p. 150).
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Dunner DL Yang T. Depression subtypes. Presented at the Second International Congress on Hormones, Brain and Neuropsychopharmacology, Rhodos, Greece, 7/15-19, 2000. 23:(S2): S113 2000 (Poster Abstract). Zajecka J, Dunner DL et al. Sexual function and satisfaction in the ireatment of chronic major depression with nefazodone, CBASPsychotherapy (CBASP) and their combination. Presented at the 39 th Annual Meeting of the American College of Neuropharmacology, San Juan, PR, Dec 10-14, 2000. Poster abstract, p. 156. Post abstract p. 157. Avery DH, Neumaier J, Roy-Byrne P, Dunner D, Tucker G, Claypoole K. TMS in the treatment of medication-resistant major depression. Presented at the 56 th annual meeting, Society of Biological Psychiatry, New Orleans, LA, 5/3-5, 2001. Biological Psychiatry 49 8S:1135-114S, 2001. Dunner DL. Ethnic and gender issues in the treatment of depression.Presented at the annual meeting, American Psychiatric Assn., New Orleans, LA, May 5-10, 2001. Abstracts p. 319. Kocsis JH, Arnow BA, Borian FE, Dunner DL, Gelenberg AJ, Keitner GI, Klein DN. Contnuation treatment with nefazodone, cognitive behavioral analysis system of psychotherapy, and their conbination for chronic depression. Presented at the annual meeting, American Psychiatric Assn., New Orleans, LA. May 5-10, 2001. New research abstracts, P. 105-106. Duimer DL, Hendrickson Bea C, Budech CB.Dysthymic Disorder: Treatment With Citalopram. Presented at the 44 th annual meeting, NCDEU. Phoenix, AZ May 28-31, 2001. Abstracts 111-32. Dunner DL. Diagnosis and managerrent of chronic depres4on. Essential Psychonharmacology 21: 247-259, 2001 (interview). Dunner DL, Hendrickson HE, Bea C, Budech C, Friedman S. Dysthymic disorder: treatment with citalopram. Presented at the 40th Annual Meeting, American College of Neuropsychopharmacology, Waikoloa, HI, Dec 9-13, 2001. (Abstract p. 135). Dunner, DL. Diagnosis and treatment of dystkimia and double depression. Presented at the Annual Meeting of Arrerican Psychiatric Assn., Philadephia, PA, May 18-23, 2002. Syllabus and scientific proceedings in summary form. American Psychiatric Assn, 2002, p. 74. Dunner DL. Putting the pieces together: Treatments for the paient and the future. Presented at the Annual Meeting of American Psychiatric Assn., Philadelphia,PA, May 18-23, 2002. Syllabus and scientific proceedings in summary form. American Psychiatric Assn., 2002, p. 282. Dunner D, Hendrickson HE, Bea C, Budech CB, Friedman S. Dysthymic disorder: treatment with citalopram. Presented at the XXIII CINP Congress, Montreal, Canada 6/23-27/2002. Int J Neuropsychopharmacology 5 (Suppl 1) S57, 2002. Dunner DL, Mallincrodt C, Lu Y,Detke M. Duloxetine is effective in reducing anxiey symptoms associated with depression. Presented at the 41' t Annual Meeting, American College of Neuropsychophannacolow, San Juan PR 12/8-12/2002. Scientific Abstract p. 133. Dunner DL, Mallincrodt C, Lu Y, Detke MJ. Duloxetine is effective in reducing anxieV symptoms associated with depression. Presented at the 58 th Annual Meeting, Society of BiologicalPsychiatry, San Francisco, CA. May 15-17, 2003. Biological Psychiatry 53: 193S, 2003. Dunner DL. The clinical challenge of depression in lipolar disorder. Presented at the 156 th Annual Meeting. American Psychiatric Assn. San Francisco, Calif. 5/17-22/2003. Sylabus and Proceedings Summary, p. 300, Dunner DL, Amsterdam JD, Shelton RC, Hassman HA, Rosenthal M,Romano SJ. Adjunctive ziprasidone in treatment-resistant depression: A pilot study. Presented at New Research, American Psychiatric Assn, May 17-22, 2003. San Francisco,CA. (NR 238). Dunner DL, Amsterdam JD, Shelton RC, Hassman HA, Rosenthal M,Romano SJ. Adjunctive ziprasidone in treatment-resistant depression: a pilot study. Presented at the 43 rd Annual Meeting, NCDEU, Boca Raton, FL. May 27-30, 2003. Abstracts p. 123. Dunner DL, Vo D, Friedman S. Treatment resistant bipolar disorder. Presented at the Fifth International Conference on Bipolar Disorder, Pittsburgh, PA. June 12-14, 2003. Bipolar disorders 2003; (Suppl 1):44.
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Duimer DL, Amsterdam JD, Shelton RC, Romano SJ and Loebel A, Adjunctive Ziprasidone in treatment-resistant depression: randomized, double-blind, 8-week pilot study. Presented at the Annual Meeting, Aimrican Psychiatric Assn at Atlanta, Georgia May 21-26, 2005. New Research p 57. Duimer DL. Influence of co-morbidity on the treatment of depression. Presented at the 158 th Annual Meeting, American Psychiatric Association, Atlanta GA. May 21-26, 2005. Syllabus and Proceedings Summary, p. 50. Bader CD, Dunner DL. Clinical characteristics of bipolar disorder not otherwise specified in relation to the bipolar spectrum. Presented at the 61 International Conference on BipolarDisorders, Pittsburgh PA, June 26-28, 2005. Bipolar Disorders 7 (Supp 2): 30, 2005. Dunner DL. A two-year longitudinal study of adjunctivevagus nerve stimulation for patients with treatment-resistant depression. Presented at the 18 th ECNP Congress, Amsterdam, The Netherlands, 0ct22-26, 2005. European Psychopharmac 15 (Suppl 3): S401, 2005. Dunner DL, Amsterdam JD, Shelton RC, Loebel A. Adjunctive ziprasidone for resistant depression: 8 week pilot study. Presented at the 18 th ECNP Congress, Amsterdam, The Netherlands, Oct 22-26, 2005. European Psychopharmac 15 (Suppl 3): S444, 2005. Dunner DL, Canuso CM, Bossie CA, Zhu Y. Underdiagnosis of psychotic symptoms in patients with bipolar mania. Presented at the 44th Annual Meeting, American College of Neuropsychopharmacology, Waikoloa HI, Dec 11-15, 2005, Neuropsychopharmacology 30, Suppl 1, S108, 2005. Brown E, Dunner D, Adams D, Degenhardt E, Tohen M, Williamson D, Houston J. Olanzapine/fluoxetine combination versus lamotrigine in the long-term treatment of bipolar I depression. Presented at the 44 th Annual Meeting, American College of Neuropsychopharmacology, Waikoloa HI, Dec 11-15, 2005, Neuropsychopharmacology 30, Suppll, S108, 2005. Brown E, Dunner D, Adams D, Degenhardt E, Tohen M, Williamson D, Houston J. Olanzapine/fluoxetine combinaticn versus lamotrigine in the long-term treatment of bipolar I depression. Presented at the 61' 1 annual meeting, Sociebt of Biological Psychiatry, Toronto, Canada, 1Vhy 18-20, 2006, Biological Psychiatry 59, Suppl 8, S25, 2006. Canuso CM, Bossie CA, Youssef E, Zhu Y, Dunner DL. Identification and treatment of psychotic symptcms in patients with bipolar mania.. Presented at the 61 4 annual meeting, Society of Biological Psychiatry, Toronto, Canada, IVIay 18-20, 2006, Biological Psychiatry 59, Suppl 8, S180, 2006. Dunner DL. Definitions and clinical characteristics of treatment-resistant depression. Presented at the 159 th Annual Meeting, American Psychiatric Association, Toronto, Canada, May 20-25, 2006. Syllabus and Proceedings Summary 12-13. Michelson D, Adler AA, Amsterdam JD, Dunner DL, Nierenberg AA, Reimherr FW, Schatzberg AF. Addition of atomoxetine for depression incompleteb, responsive to sertraline: a randomized, double-blind, placebo-controlled study. Presented at the 159 th Annual Meeting, American Psychiatric Association, Toronto, Canada,May 20-25, 2006. Syllabus and Proceedings Summary 74. Brown E, Dunner D, Adams D, Degenhardt E, Tohen M, Williamson D, Houston J. Olanzapine/fluoxetine combination versus larnotrigine in the long-term treatment of bipolar I depression. Presented at the 159 th Annual Meeting, American Psychiatric Association, Toronto, Canada, May 20-25, 2006. New Research 189. Dunner DL, Bossie CA, Youssef E, Zhu Y, McLemoreBS, Canuso CM. Identification and treatment of psychoticsymptoms in patients with bipolar mania. Presented at the 159 th Annual Meeting, American Psychiatric Association, Toronto, Canada, May 2025, 2006. New Research 207. Duimer DL, Rush AJ, Russell JM, Burke M, Woodward S, WingardP, Allen J. Prospective, ling-term, multicenter study of the naturalistic outcomes of treatment-resistant depression. Presented atthe 159 th Annual Meeting, American Psychiatric Association, Toronto, Canada, May 20-25, 2006, New Research 208 Keller MB, Yan B, Thase ME, Dunner D, Trivedi MH, Rothschild AJ,Kornstein SG. Recurrence prevention: Efficacy of two years of maintenance treatment withvenlafaxine XR in patients with recurrent unipolar major deccession. Presented at the 159 th Annual Meeting, American Psychiatric Association, Toronto, Canada, May 20-25, 2006. New Research 528.
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