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| Sponsor: | Maine Medical Center |
|---|---|
| Collaborator: |
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 six 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Early Detection and Intervention for the Prevention of Psychosis Project |
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
This is the control arm. Participants will be offered only case management.
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Experimental: 2
This is the experimental intervention arm for high-risk-for-psychosis participants.
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Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Oral, daily, generally at lower than manufacturer's recommendations
Other Names:
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
Other Names:
Behavioral: Supported employment and education
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
Other Names:
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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 six sites include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; Albuquerque, New Mexico 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California-Davis, Imaging Research Center | |
| Sacramento, California, United States, 95817 | |
| United States, Maine | |
| Portland Identification and Early Referral Program | |
| Portland, Maine, United States, 04102 | |
| United States, Michigan | |
| Washtenaw County | |
| Ann Arbor, Michigan, United States, 48108 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| United States, New York | |
| Zucker Hillside Hosptial | |
| Glen Oaks, New York, United States, 11004 | |
| United States, Oregon | |
| Mid-Valley Behavioral Care Network | |
| Salem, Oregon, United States, 97301 | |
| Principal Investigator: | William R. McFarlane, M.D. | Maine Medical Center |
More Information
| Responsible Party: | Donald St. Germain, M.D., Maine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00531518 History of Changes |
| Other Study ID Numbers: | 58920, RWJF #58920 |
| Study First Received: | September 18, 2007 |
| Last Updated: | August 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
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Bipolar Disorder Depression Depressive Disorder Mental Disorders Psychotic Disorders Schizophrenia Affective Disorders, Psychotic Mood Disorders Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features Fluoxetine Sertraline Bupropion Lamotrigine Aripiprazole |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Cardiovascular Agents |
