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Early Detection and Intervention for the Prevention of Psychosis, A Multi-Site Study (EDIPP)
This study is currently recruiting participants.
Study NCT00531518   Information provided by Maine Medical Center
First Received: September 18, 2007   Last Updated: May 6, 2009   History of Changes

September 18, 2007
May 6, 2009
October 2007
April 2011   (final data collection date for primary outcome measure)
Conversion to psychosis [ Time Frame: two years ] [ Designated as safety issue: No ]
Conversion to psychosis [ Time Frame: two years ]
Complete list of historical versions of study NCT00531518 on ClinicalTrials.gov Archive Site
Social and occupational functioning [ Time Frame: two years ] [ Designated as safety issue: No ]
Social and occupational functioning [ Time Frame: two years ]
 
Early Detection and Intervention for the Prevention of Psychosis, A Multi-Site Study
Early Detection and Intervention for the Prevention of Psychosis Project

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.

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.

 
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Schizophrenia
  • Bipolar Disorder
  • Depression
  • Psychotic Disorders
  • Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
  • Behavioral: Psychoeducational multifamily group treatment
  • Behavioral: Supported employment and education
  • No Intervention: This is the control arm. Participants will be offered only case management.
  • Experimental: This is the experimental intervention arm for high-risk-for-psychosis participants.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
900
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years to 25 Years
No
Contact: William R. McFarlane, M.D. 207-662-2091 mcfarw@mmc.org
Contact: William L. Cook, Ph.D 207-662-2091 cookw@mmc.org
United States
 
NCT00531518
James Donovan, Assoc V.P. Medical Affairs, Maine Medical Center
58920, RWJF #58920
Maine Medical Center
Robert Wood Johnson Foundation
Principal Investigator: William R. McFarlane, M.D. Maine Medical Center
Maine Medical Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP