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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531518
Recruitment Status : Completed
First Posted : September 19, 2007
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center

Tracking Information
First Submitted Date  ICMJE September 18, 2007
First Posted Date  ICMJE September 19, 2007
Results First Submitted Date  ICMJE January 20, 2016
Results First Posted Date  ICMJE August 15, 2016
Last Update Posted Date August 15, 2016
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
Psychotic Symptoms [ Time Frame: two years ]
Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2007)
Conversion to psychosis [ Time Frame: two years ]
Change History Complete list of historical versions of study NCT00531518 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2007)
Social and occupational functioning [ Time Frame: two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Early Detection and Intervention for the Prevention of Psychosis
Official Title  ICMJE Early Detection and Intervention for the Prevention of Psychosis Project
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Schizophrenia
  • Bipolar Disorder
  • Depression
  • Psychotic Disorders
Intervention  ICMJE
  • Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
    Oral, daily, generally at lower than manufacturer's recommendations
    Other Names:
    • Abilify
    • Prozac
    • Welbutrin
    • Zoloft
    • Lamictal
  • 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
    Other Names:
    • Family psychoeducation,
    • Family behavioral therapy
    • Multiple family group therapy
  • Behavioral: Supported employment and education
    Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
    Other Names:
    • Supported employment
    • Supported education
Study Arms  ICMJE
  • No Intervention: Control group
    This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
  • Experimental: Family-aided Assertive Community Treatment
    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 .
    • Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
    • Behavioral: Psychoeducational multifamily group treatment
    • Behavioral: Supported employment and education
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2007)
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00531518
Other Study ID Numbers  ICMJE 58920
RWJF #58920 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Currently, on request, data will be shared with legitimate organizations for specific analyses approved by the PI and the Maine Medical Center Institutional Review Board.
Responsible Party William McFarlane, Maine Medical Center
Study Sponsor  ICMJE Maine Medical Center
Collaborators  ICMJE Robert Wood Johnson Foundation
Investigators  ICMJE
Principal Investigator: William R. McFarlane, M.D. Maine Medical Center
PRS Account Maine Medical Center
Verification Date July 2016

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