Early Detection and Intervention for the Prevention of Psychosis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Bipolar Disorder Depression Psychotic Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.

Group Type NO_INTERVENTION

No interventions assigned to this group

Family-aided Assertive Community Treatment

This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .

Group Type EXPERIMENTAL

aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine

Intervention Type DRUG

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

Psychoeducational multifamily group treatment

Intervention Type BEHAVIORAL

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

Supported employment and education

Intervention Type BEHAVIORAL

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

Interventions

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aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine

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

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Supported employment and education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Abilify Prozac Welbutrin Zoloft Lamictal Family psychoeducation, Family behavioral therapy Multiple family group therapy Supported employment Supported education

Eligibility Criteria

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Exclusion 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.

* Outside the age range of 12 to 25 years;
* History of intelligence quotient (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 Positive Symptom sub-scale of the Scale of Positive Symptoms (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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No