Early Detection and Intervention for the Prevention of Psychosis

Depression Clinical Trial

— EDIPP  

Official title:

Early Detection and Intervention for the Prevention of Psychosis Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531518
• Other study ID #: 58920
• Secondary ID: RWJF #58920
• Status: Completed
• Phase: N/A
• First received: September 18, 2007
• Last updated: October 22, 2015
• Start date: October 2007
• Est. completion date: September 2013

Study information

• Verified date: October 2015
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3337
• Est. completion date: September 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

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 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 psychosis scales of the SIPS/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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Washtenaw County	Ann Arbor	Michigan
United States	Zucker Hillside Hosptial	Glen Oaks	New York
United States	Portland Identification and Early Referral Program	Portland	Maine
United States	University of California-Davis, Imaging Research Center	Sacramento	California
United States	Mid-Valley Behavioral Care Network	Salem	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Maine Medical Center	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to psychosis	Conversion to psychosis is measured by emergence of positive psychotic symptoms, at the level of "6" on the Structured Interview for the Prodromal Syndrome scale, for [1] at least one day, or [2] for thirty days, at least one hour on at least four days per week.	two years	No
Secondary	Social and occupational functioning	Social and Occpuational Functioining are measured using the Global Assessment of Functioning, Social and Role Scales. At each time point a reliable interviewer rates the current social and role functioinning, separately, on a scale of 0-100. Functioning is also measured by the Heinrich's Quality of Life Scale, which provides separate ratings for domains of functioining and a composite overall score.	two years	No

External Links

•   Describes the orientation of the program and early signs of psychosis
•   Describes the program and policy implications of the study