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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Depression Psychotic Disorders Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine Behavioral: Psychoeducational multifamily group treatment Behavioral: Supported employment and education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Detection and Intervention for the Prevention of Psychosis Project
Study Start Date : October 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00531518

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United States, California
University of California-Davis, Imaging Research Center
Sacramento, California, United States, 95817
United States, Maine
Portland Identification and Early Referral Program
Portland, Maine, United States, 04102
United States, Michigan
Washtenaw County
Ann Arbor, Michigan, United States, 48108
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
Zucker Hillside Hosptial
Glen Oaks, New York, United States, 11004
United States, Oregon
Mid-Valley Behavioral Care Network
Salem, Oregon, United States, 97301
Sponsors and Collaborators
Maine Medical Center
Robert Wood Johnson Foundation
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Principal Investigator: William R. McFarlane, M.D. Maine Medical Center

Additional Information:
Publications of Results:
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Responsible Party: William McFarlane, Principal Investigator, Maine Medical Center Identifier: NCT00531518     History of Changes
Other Study ID Numbers: 58920
RWJF #58920 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
First Posted: September 19, 2007    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
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.
Keywords provided by William McFarlane, Maine Medical Center:
Bipolar disorder
Prodromal psychosis
Family psychoeducation
Supported education
Supported employment
Ulra-high-risk for psychosis
Major depression
Bipolar disorder, with psychotic features
Major depression, with psychotic features
Attenuated, prodromal psychotic symptoms
Additional relevant MeSH terms:
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Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists