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Psychosis: Early Detection, Intervention and Prevention

NCT01597141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-02-08

Study results available
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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.

Conditions

  • Prodromal Schizophrenia
  • Psychotic Disorders
  • Severe Bipolar Disorder With Psychotic Features
  • Severe Major Depression With Psychotic Features

Interventions

BEHAVIORAL

Family-aided Assertive Community Treatment

The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.

BEHAVIORAL

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

Sponsors & Collaborators

Principal Investigators

  • William R McFarlane, M.D. · MaineHealth

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597141 on ClinicalTrials.gov