Clinical trial NCT01597141: Psychosis: Early Detection, Intervention and Prevention
Official title: Psychosis: Early Detection, Intervention and Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prodromal Schizophrenia
Psychotic Disorders
Severe Bipolar Disorder With Psychotic Features
Severe Major Depression With Psychotic Features
Keywords: Prodromal
Schizophrenia
Psychosis
Family psychoeducation
Assertive community treatment
Supported employment
Supported education
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Harvard University
name: University of California, Irvine
First posted: 2012-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

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 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

Primary outcomes:
measure: Onset of Psychosis
timeFrame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months
Secondary outcomes:
measure: Functioning
timeFrame: 24 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: William R McFarlane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McFarlane WR, Susser E, McCleary R, Verdi M, Lynch S, Williams D, McKeague IW. Reduction in incidence of hospitalizations for psychotic episodes through early identification and intervention. Psychiatr Serv. 2014 Oct;65(10):1194-200. doi: 10.1176/appi.ps.201300336.
citation: Woodberry KA, McFarlane WR, Giuliano AJ, Verdi MB, Cook WL, Faraone SV, Seidman LJ. Change in neuropsychological functioning over one year in youth at clinical high risk for psychosis. Schizophr Res. 2013 May;146(1-3):87-94. doi: 10.1016/j.schres.2013.01.017. Epub 2013 Feb 22.
citation: McFarlane WR, Cook WL, Downing D, Verdi MB, Woodberry KA, Ruff A. Portland identification and early referral: a community-based system for identifying and treating youths at high risk of psychosis. Psychiatr Serv. 2010 May;61(5):512-5. doi: 10.1176/appi.ps.61.5.512.