Early Detection and Intervention for the Prevention of Psychosis

Study Overview
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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.

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.

Official Title
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Early Detection and Intervention for the Prevention of Psychosis Project

Conditions
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Schizophrenia, Bipolar Disorder, Depression, Psychotic Disorders

Intervention / Treatment
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* Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
* Behavioral: Psychoeducational multifamily group treatment
* Behavioral: Supported employment and education


Participation Criteria
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Eligibility Criteria
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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; 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: 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff. | |
| Experimental: Family-aided Assertive Community Treatment<br>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 . | Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine<br>* Oral, daily, generally at lower than manufacturer's recommendations<br>* Other names: Lamictal;Behavioral: Psychoeducational multifamily group treatment<br>* 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<br>* Other names: Multiple family group therapy;Behavioral: Supported employment and education<br>* Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.<br>* Other names: Supported education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic Symptoms | Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Schizophrenia, Bipolar disorder, 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