NCT00531518

Early Detection and Intervention for the Prevention of Psychosis

Early Detection and Intervention for the Prevention of Psychosis Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: MaineHealth · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Bipolar Disorder
• Depression
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine	Oral, daily, generally at lower than manufacturer's recommendations
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
BEHAVIORAL	Supported employment and education	Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.

Timeline

• Start date: 2007-10-01
• Primary completion: 2013-05-01
• Completion: 2013-09-01
• First posted: 2007-09-19
• Last updated: 2016-08-15
• Results posted: 2016-08-15

Locations

6 sites across 1 country: United States