Psychosis: Early Detection, Intervention and Prevention

Psychotic Disorders Clinical Trial

— EDIP  

Official title:

Psychosis: Early Detection, Intervention and Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597141
• Other study ID #: 1R01MH065367-01A1
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: January 7, 2016
• Start date: May 2003
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder, Major
• Disease
• Mental Disorders
• Prodromal Schizophrenia
• Psychotic Disorders
• Schizophrenia
• Schizotypal Personality Disorder
• Severe Bipolar Disorder With Psychotic Features
• Severe Major Depression With Psychotic Features

Intervention

Behavioral:
• Family-aided Assertive Community Treatment
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
• 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

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (4)

Lead Sponsor	Collaborator
Maine Medical Center	Columbia University, Harvard University, University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.p — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Functioning	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.	24 months	No

External Links

•   Describes risk factors for psychosis, current scientific understanding of psychosis and means of accessing services