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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Maine Medical Center.
Recruitment status was  Active, not recruiting
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: March 19, 2012
Last verified: March 2012
  Purpose

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 Intervention
Schizophrenia
Bipolar Disorder
Depression
Psychotic Disorders
Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Behavioral: Psychoeducational multifamily group treatment
Behavioral: Supported employment and education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Detection and Intervention for the Prevention of Psychosis Project

Resource links provided by NLM:


Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Conversion to psychosis [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Social and occupational functioning [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 350
Study Start Date: October 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
This is the control arm. Participants will be offered only case management.
Experimental: 2
This is the experimental intervention arm for high-risk-for-psychosis participants.
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531518

Locations
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
Investigators
Principal Investigator: William R. McFarlane, M.D. Maine Medical Center
  More Information

No publications provided

Responsible Party: William McFarlane, Principal Investigator, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00531518     History of Changes
Other Study ID Numbers: 58920, RWJF #58920
Study First Received: September 18, 2007
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Maine Medical Center:
Schizophrenia
Bipolar disorder
Psychosis
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:
Bipolar Disorder
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Fluoxetine
Sertraline
Bupropion
Lamotrigine
Aripiprazole
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 28, 2014