Psychosis: Early Detection, Intervention and Prevention
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|
|Start date||May 2003|
|End date||September 2014|
|Trial size||100 participants|
|Trial identifier||NCT01597141, 1 R01 MH065367-01A1|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Onset of psychosis
time frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months
time frame: Baseline, 6, 12, 18 24 and 60 months
Incidence of first hospitalizations for a psychotic episode
time frame: 1993-2007
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
|Official title||Psychosis: Early Detection, Intervention and Prevention|
|Principal investigator||William R McFarlane, M.D.|
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