Psychosis: Early Detection, Intervention and Prevention (EDIP)

This study has been completed.
Sponsor:
Collaborators:
Columbia University
Harvard University
University of California, Irvine
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT01597141
First received: May 9, 2012
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.

Condition Intervention
Prodromal Schizophrenia
Psychotic Disorders
Severe Bipolar Disorder With Psychotic Features
Severe Major Depression With Psychotic Features
Behavioral: Family-aided Assertive Community Treatment
Behavioral: Enhanced standard treatment

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: Psychosis: Early Detection, Intervention and Prevention

Resource links provided by NLM:


Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Onset of Psychosis [ Time Frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months ] [ Designated as safety issue: No ]
    Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.


Secondary Outcome Measures:
  • Functioning [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.


Enrollment: 100
Study Start Date: May 2003
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family-aided Assertive Community Treatment
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Behavioral: Family-aided Assertive Community Treatment
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Active Comparator: Enhanced standard treatment
In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Behavioral: Enhanced standard treatment
In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention

Detailed Description:

The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.

The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prodromal psychotic symptoms
  • Age 12-35
  • In catchment area (greater Portland, Maine)

Exclusion Criteria:

  • Previous or current psychotic episode
  • IQ less than 70
  • Outside catchment area
  • Toxic psychosis
  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: NCT01597141

Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center
Columbia University
Harvard University
University of California, Irvine
Investigators
Principal Investigator: William R McFarlane, M.D. Maine Medical Center Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: William McFarlane, Principal Investigator, Maine Medical Center
ClinicalTrials.gov Identifier: NCT01597141     History of Changes
Other Study ID Numbers: 1R01MH065367-01A1 
Study First Received: May 9, 2012
Results First Received: October 22, 2015
Last Updated: January 7, 2016
Health Authority: United States: Federal Government

Keywords provided by Maine Medical Center:
Prodromal
Schizophrenia
Psychosis
Family psychoeducation
Assertive community treatment
Supported employment
Supported education

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder, Major
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizotypal Personality Disorder
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders
Pathologic Processes
Personality Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 26, 2016