Early Detection and Intervention for the Prevention of Psychosis (EDIPP)

MaineHealth

Status: Completed

Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder; Depression

Treatments: Behavioral: Supported employment and education; Behavioral: Psychoeducational multifamily group treatment; Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT00531518

RWJF #58920 (Other Grant/Funding Number)

58920

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 292 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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292 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Family-aided Assertive Community Treatment

Experimental group

Description:

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 .

Treatment:

Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine

Behavioral: Supported employment and education

Behavioral: Psychoeducational multifamily group treatment