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

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT00531518
First received: September 18, 2007
Last updated: July 6, 2016
Last verified: July 2016

September 18, 2007
July 6, 2016
October 2007
May 2013   (final data collection date for primary outcome measure)
Psychotic Symptoms [ Time Frame: two years ] [ Designated as safety issue: No ]
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.
Conversion to psychosis [ Time Frame: two years ]
Complete list of historical versions of study NCT00531518 on ClinicalTrials.gov Archive Site
Not Provided
Social and occupational functioning [ Time Frame: two years ]
Not Provided
Not Provided
 
Early Detection and Intervention for the Prevention of Psychosis
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
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Schizophrenia
  • Bipolar Disorder
  • Depression
  • Psychotic Disorders
  • 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
  • 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 .
    Interventions:
    • Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
    • Behavioral: Psychoeducational multifamily group treatment
    • Behavioral: Supported employment and education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
September 2013
May 2013   (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 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.
Both
12 Years to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00531518
58920, RWJF #58920
Yes
Yes
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.
William McFarlane, Maine Medical Center
Maine Medical Center
Robert Wood Johnson Foundation
Principal Investigator: William R. McFarlane, M.D. Maine Medical Center
Maine Medical Center
July 2016

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