Overview

This trial is active, not recruiting.

Conditions prodromal schizophrenia, psychotic disorders, severe bipolar disorder with psychotic features, severe major depression with psychotic features
Treatments family-aided assertive community treatment, enhanced standard treatment
Sponsor Maine Medical Center
Collaborator Columbia University
Start date May 2003
End date September 2014
Trial size 100 participants
Trial identifier NCT01597141, 1 R01 MH065367-01A1

Summary

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 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 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. 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 96 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
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)
In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
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

Primary Outcomes

Measure
Onset of psychosis
time frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months

Secondary Outcomes

Measure
Functioning
time frame: Baseline, 6, 12, 18 24 and 60 months
Incidence of first hospitalizations for a psychotic episode
time frame: 1993-2007

Eligibility Criteria

Male or female participants from 12 years up to 35 years old.

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

Additional Information

Official title Psychosis: Early Detection, Intervention and Prevention
Principal investigator William R McFarlane, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Maine Medical Center.