Psychosis: Early Detection, Intervention and Prevention
EDIP
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
February 8, 2016
CompletedFebruary 8, 2016
January 1, 2016
11.3 years
May 9, 2012
October 22, 2015
January 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Onset of Psychosis
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.
From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months
Secondary Outcomes (1)
Functioning
24 months
Study Arms (2)
Family-aided Assertive Community Treatment
EXPERIMENTALThe experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Enhanced standard treatment
ACTIVE COMPARATORIn this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Interventions
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Eligibility Criteria
You may qualify if:
- Prodromal psychotic symptoms
- Age 12-35
- In catchment area (greater Portland, Maine)
You may not qualify if:
- Previous or current psychotic episode
- IQ less than 70
- Outside catchment area
- Toxic psychosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MaineHealthlead
- Columbia Universitycollaborator
- Harvard Universitycollaborator
- University of California, Irvinecollaborator
Study Sites (1)
Maine Medical Center
Portland, Maine, 04102, United States
Related Publications (3)
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.
PMID: 24632857BACKGROUNDWoodberry 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.
PMID: 23434505BACKGROUNDMcFarlane 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.
PMID: 20439374RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- William R. McFarlane, M.D.
- Organization
- Maine Medical Center Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
William R McFarlane, M.D.
MaineHealth
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 11, 2012
Study Start
May 1, 2003
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
February 8, 2016
Results First Posted
February 8, 2016
Record last verified: 2016-01