Schizophrenia Forum

John M. Kane, M.D.

Chairman, Department of Psychiatry
The Zucker Hillside Hospital
 Disclosure: John M. Kane, MD Past 5 Years
Grants/
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 The NIMH RAISE Project
 NIMH awarded separate contracts to 2 independent
research teams:
– The Early Treatment Program at the Feinstein Institute for
Medical Research in Manhasset, NY
– The Connection Program at the Research Foundation for
Mental Hygiene at Columbia University in New York, NY

 The Early Treatment Program has been funded in

whole or in part with Federal funds from the American
Recovery and Reinvestment Act of 2009 and the
NIMH/NIH/HHS under Contract No. HHSN-271-2009-
00019C
 RAISE Early Treatment Program
Executive Committee

 John Kane, MD- Principal Investigator

 Delbert Robinson, MD- The Zucker Hillside Hospital
 Nina Schooler, PhD- SUNY Downstate
 Jean Addington, PhD- University of Calgary
 Sue Estroff, PhD- University of N Carolina
 Christoph Correll, MD- The Zucker Hillside Hospital
 Kim Mueser, PhD- Dartmouth University
 David Penn, PhD- University of N Carolina
 Robert Rosenheck, MD- Yale University
 Patricia Marcy, RN, Project Director
 NIMH RAISE ETP Project Team

• Bruce Anderson, Contracting Officer

• Susan Azrin, Project Officer
• Jean Baum, Project Communications
• Amy Goldstein, Associate Project Director
• Phil Hastings-Tickertoff, Contract Specialist
• Robert Heinnsen, Project Director
• Joanne Severe, Clinical Trial Operations
• Christine Ulbricht, Administration and Communications
 Clinical Characteristics of First
Episode Psychosis
 Typically adolescent or young adult
 Families are often actively engaged
 Goals are to return to mainstream
functioning
 Have lived with severe untreated psychotic
symptoms
– On average for at least a year
 Compared to peers
– Cognitively impaired
– Poorer psychosocial functioning
– More likely to smoke
– More likely to abuse substances
 Substance Abuse in First Episode
Psychosis Patients
 Alcohol or any drug misuse/abuse occur in 37-
70%
– Much higher rates than in people without psychosis
– More common in males and younger patients
– Associated with age of onset in some samples
– Persistent use associated with non-adherence and
worse course of illness
– Substance use disorders respond best to integrated
treatment (treat psychosis and SUD together)
 The Risk for Psychotic Relapse is High

95% limit (%)

Relapse Patients still at
Year* rate (%) Lower Upper risk at end of year
1 16.2 8.9 23.4 80
2 53.7 43.4 64.0 39
3 63.1 52.7 73.4 22
4 74.7 64.2 85.2 9
5 81.9 70.6 93.2 4

n=104 first-episode schizophrenia

patients
*Year(s) since previous episode
Robinson D, et al. Arch Gen Psychiatry 1999;56:241–7
Targets for Psychosocial Interventions

 Isolation from families and friends

 Damage to social and working relationships
 Risk of self-harm and aggression
 Substance abuse
 Self stigma
 Demoralization and depression
 Family disruption and distress
 Disrupted developmental trajectory
 Coping with symptoms and poor cognition
 Essential Elements in First Episode
Intervention
 Specialized track with trained team
 Strategies for initial and sustained engagement
 Personalized psychopharmacologic treatment
 Medical management and liaison with primary
care
 Psychosocial treatments
– Individual therapy
– Family treatment
– Supportive employment/education
 Components of ETP NAVIGATE
Intervention
 Personalized psychopharmacological treatment
and medical management
 Family psychoeducation/treatment
 Supported education/employment
 Individual resiliency training
 Team of professionals share responsibility for
treating clients in NAVIGATE program
 All components individually tailored to client and
family goals established early in treatment
 Shared decision-making model informs all
treatment
 ETP NAVIGATE Intervention
Team Roles
 Director
– Provides family psychoeducation
– Supervises clinicians and SEE specialist
– Manages the first episode program, runs meetings
– Conducts outreach and engagement
 Clinicians
– Provide case management
– Provide Individual Resiliency Training
 Supported education/employment (SEE) specialist
– Facilitates client’s education and work goals
– Coordinates with clinical team
 Prescriber-Psychiatrist or Nurse Practitioner
– Psychopharmacologic treatment and medical
management
 Core Competencies of the
ETP NAVIGATE Team

 Shared decision-making
 Strengths and resiliency focus
 Motivational enhancement skills
 Psychoeducational skills
 Cognitive-behavioral skills
 Collaboration with community supports
 ETP NAVIGATE
Pharmacological Treatment
 Medication Algorithm
– Based upon the 2007 TMAP algorithm
 Computerized Decision Support System to
guide medication decisions
– Measurement-based assessment of therapeutic
and adverse effects
 Individually tailored, based on shared
decision- making
 Medical management
Computerized Decision Support System
Longitudinal Symptom Assessment
Figure 1. Patient Evaluation Screen
RAISE-ETP Site Distribution
35 sites, 21 States
 ETP Trial Design: Subjects
 Sample size: 400
 Age 16-40
 The following diagnoses are included in the
differential
―schizophreniform disorder
―schizophrenia
―schizoaffective disorder
―psychotic disorder NOS
―brief psychotic disorder
 Less than four months of treatment with
antipsychotic medications
 ETP Trial: Methods
 Sites are randomly assigned to administer either
the NAVIAGATE Intervention or their current
community care treatment program
 A central team of raters conducts structured
diagnostic interviews and assesses subjects via
live, two-way video interviews
― Assessors are masked to treatment condition
 Compatible with the site randomization model
― Expert assessors available to all sites
― Central rater team allows ongoing maintenance of
high reliability of assessment
 Subjects are assessed for a minimum of 2 years
 ETP Trial: Outcomes

 Primary outcome measure: Quality of Life scale

– Primary hypothesis
• NAVIGATE intervention compared to community care will
improve Quality of Life
 Other measured outcomes
– Service utilization
– Cost
– Consumer perception
– Prevention of relapse
– Enhanced recovery
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