Early Detection and Intervention for the Prevention of Psychosis, A Multisite Study - Full Text View

Sponsors and Collaborators:	Maine Medical Center Robert Wood Johnson Foundation
Information provided by:	Maine Medical Center
ClinicalTrials.gov Identifier:	NCT00531518

Purpose

EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at five sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.

Condition	Intervention
Schizophrenia Bipolar Disorder Depression Psychotic Disorders	Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine Behavioral: Psychoeducational multifamily group treatment Behavioral: Supported employment and education

MedlinePlus related topics: Bipolar Disorder Depression Psychotic Disorders Schizophrenia

Drug Information available for: Sertraline hydrochloride Sertraline Fluoxetine Aripiprazole Lamotrigine Bupropion hydrochloride Bupropion Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Early Detection and Intervention for the Prevention of Psychosis Project

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:

Conversion to psychosis [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Social and occupational functioning [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention This is the control arm. Participants will be offered only case management.
2: Experimental This is the experimental intervention arm for high-risk-for-psychosis participants.	Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine Oral, daily, generally at lower than manufacturer's recommendations Behavioral: Psychoeducational multifamily group treatment Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work Behavioral: Supported employment and education Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.

Arms

Assigned Interventions

1: No Intervention

This is the control arm. Participants will be offered only case management.

2: Experimental

This is the experimental intervention arm for high-risk-for-psychosis participants.

Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine

Oral, daily, generally at lower than manufacturer's recommendations

Behavioral: Psychoeducational multifamily group treatment

Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work

Behavioral: Supported employment and education

Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.

Detailed Description:

The study is structured as a cutoff, regression discontinuity design, in which lower risk-for-psychosis participants will not be treated by protocol but followed up for two years. Those at higher risk will be treated with anti-psychotic, antidepressant and mood stabilizing medications by symptom indications, and systematically provided psychoeducational multifamily group treatment, supported education and employment, and intensive clinical case management, using key elements of Assertive Community Treatment. Both arms of the study will be followed for two years and assessed at 6, 12, and 24 months. Outcome measures include rates of conversion to psychosis, relapse of psychosis, development of psychotic disorder diagnoses, levels of positive, negative and general symptoms, social and vocational functioning, family functioning, and neurocognitive functioning.

The five sites will include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; and Glen Oaks, New York.

In addition to symptomatic and functional outcomes, impact on incidence of psychotic disorders, including schizophrenia, will be assessed, as will cost-benefit effects.

Eligibility

Ages Eligible for Study:	12 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects in the age range of 12-25 and living in the experimental catchment area may be enrolled in the EDIPP study based on meeting at least one of the inclusion requirements AND none of the exclusion criteria.

Inclusion Criteria

Screening process indicates symptoms equivalent to a minimum rating of '1' on at least one positive symptom of psychosis;
Screening process indicates a likely family history of first degree relative with psychotic illness plus a deterioration in functioning equivalent to a 30% drop in functioning score over the past year; OR
Screening process indicates a likely history of schizotypal personality disorder plus a deterioration in functioning equivalent to a 30% drop in functioning over the past year.

Exclusion Criteria:

Subjects are excluded if:

Outside the age range of 12 to 25 years;
History of IQ below 70 (based on school records, not tested at PIER);
More than one month duration of psychosis (guided by the criteria of at least one 6 on the psychosis scales of the SIPS/SOPS);
History of previous psychotic episode, whether or not treatment was received;
Taken antipsychotic medication for more than 30 days at a therapeutic dose for psychotic symptoms;
Either the young person being screened for the study or both parents do not speak proficient English;
Female is pregnant at baseline (inquired on the screening interview); AND
Subject is a prisoner.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531518

Contacts

Contact: William R. McFarlane, M.D.	207-662-2091	mcfarw@mmc.org
Contact: William L. Cook, Ph.D	207-662-2091	cookw@mmc.org

Locations

United States, California
University of California-Davis, Imaging Research Center	Recruiting
Sacramento, California, United States, 95817
Contact: Cameron Carter, M.D. 916-734-3230 cameron.carter@ucdmc.ucdavis.edu
Contact: Daniel Ragland, Ph.D. 916.734.5802 jdragland@ucdavis.edu
Principal Investigator: Cameron Carter, M.D.
United States, Maine
Portland Identification and Early Referral Program	Recruiting
Portland, Maine, United States, 04102
Contact: William McFarlane, M.D. 207-662-2091 mcfarw@mmc.org
Contact: William L. Cook, Ph.D. 207-662-2091 cookw@mmc.org
Principal Investigator: William R. McFarlane, M.D.
United States, Michigan
Washtenaw County	Recruiting
Ann Arbor, Michigan, United States, 48108
Contact: Karen Milner, M.D. 734-936-5879 kmilner@umich.edu
Contact: Elizabeth Spring, R.N. 734.368.8794 springe@washtenaw.org
Principal Investigator: Karen Milner, M.D.
United States, New York
Zucker Hillside Hosptial	Recruiting
Glen Oaks, New York, United States, 11004
Contact: Barbara Cornblatt, Ph.D. 718-470-8133 cornblat@lij.edu
Contact: Christopher Smith, Ph.D 718.470.8286 csmith@lij.edu
Principal Investigator: Barbara Cornblatt, Ph.D.
United States, Oregon
Mid-Valley Behavioral Care Network	Recruiting
Salem, Oregon, United States, 97301
Contact: Rod Calkins, Ph.D. 503-585-4978 rcalkins@co.marion.or.us
Contact: Tamara Sale 503.361.2796 tsale@mvbcn.org
Principal Investigator: Rod Calkins, Ph.D.

Sponsors and Collaborators

Maine Medical Center

Robert Wood Johnson Foundation

Investigators

Principal Investigator:

William R. McFarlane, M.D.

Maine Medical Center

More Information

Describes the orientation of the program and early signs of psychosis This link exits the ClinicalTrials.gov site

Describes the clinical and scientific basis for the program and information for professionals about psychosis and its prevention through early intervention. This link exits the ClinicalTrials.gov site

Responsible Party:	Maine Medical Center ( James Donovan, Assoc V.P. Medical Affairs )
Study ID Numbers:	58920, RWJF #58920
Study First Received:	September 18, 2007
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00531518
Health Authority:	United States: Institutional Review Board

Keywords provided by Maine Medical Center:

Schizophrenia
Bipolar disorder
Psychosis
Prodromal psychosis
Family psychoeducation
Supported education

Supported employment
Ulra-high-risk for psychosis
Major depression
Bipolar disorder, with psychotic features
Major depression, with psychotic features
Attenuated, prodromal psychotic symptoms

Study placed in the following topic categories:

Depression
Bipolar Disorder
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Fluoxetine
Schizophrenia
Calcium, Dietary
Affective Disorders, Psychotic

Mental Disorders
Bupropion
Mood Disorders
Lamotrigine
Sertraline
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Central Nervous System Depressants
Cardiovascular Agents

Antipsychotic Agents
Pharmacologic Actions
Membrane Transport Modulators
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009