Clinical trial NCT00531518
Conditions: Schizophrenia Bipolar Disorder Depression Psychotic Disorders
Keywords: 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
Sponsor: MaineHealth
Start date: 2007-10-01; Completion date: 2013-09-01
Enrollment: 292 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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:
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.

Arms: arm 1: This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff. arm 2: 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 .
Interventions: intervention 1: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine intervention 2: Psychoeducational multifamily group treatment intervention 3: Supported employment and education
Intervention descriptions: intervention 1: Oral, daily, generally at lower than manufacturer's recommendations intervention 2: 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 3: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.

Protocol documents: