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Psychosis: Early Detection, Intervention and Prevention (EDIP)

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ClinicalTrials.gov Identifier: NCT01597141
Recruitment Status : Completed
First Posted : May 11, 2012
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Collaborators:
Columbia University
Harvard University
University of California, Irvine
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Prodromal Schizophrenia
Psychotic Disorders
Severe Bipolar Disorder With Psychotic Features
Severe Major Depression With Psychotic Features
Interventions Behavioral: Family-aided Assertive Community Treatment
Behavioral: Enhanced standard treatment
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Family-aided ACT Enhanced Treatment
Hide Arm/Group Description

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

Family-aided Assertive Community Treatment: 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.

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

Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Family-aided ACT Enhanced Treatment Total
Hide Arm/Group Description

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

Family-aided Assertive Community Treatment: 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.

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

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
16.48  (3.07) 16.12  (2.75) 16.3  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
24
  48.0%
24
  48.0%
48
  48.0%
Male
26
  52.0%
26
  52.0%
52
  52.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Hispanic 0 4 4
Non-Hispanic 50 46 96
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50 50 100
Global Assessment of Functioning (GAF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on GAF scale
Number Analyzed 50 participants 50 participants 100 participants
40.16  (13.93) 36.39  (10.35) 39.7  (12.1)
[1]
Measure Description: The 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 and 0 the 3 lowest.
1.Primary Outcome
Title Onset of Psychosis
Hide Description 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.
Time Frame From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Family-aided ACT Enhanced Treatment
Hide Arm/Group Description:

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

Family-aided Assertive Community Treatment: 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.

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

Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: percentage of sample converting
10 14
2.Secondary Outcome
Title Functioning
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.
Arm/Group Title Family-aided Assertive Community Treatment Enhanced Standard Treatment
Hide Arm/Group Description:

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

Family-aided Assertive Community Treatment: 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.

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

Overall Number of Participants Analyzed 35 34
Mean (Standard Deviation)
Unit of Measure: units on GAF scale
59.83  (16.38) 54.68  (13.38)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Family-aided Assertive Community Treatment Enhanced Standard Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Family-aided Assertive Community Treatment Enhanced Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Family-aided Assertive Community Treatment Enhanced Standard Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/50 (2.00%)      1/50 (2.00%)    
Psychiatric disorders     
Suicide   1/50 (2.00%)  1 1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Family-aided Assertive Community Treatment Enhanced Standard Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William R. McFarlane, M.D.
Organization: Maine Medical Center Research Institute
Phone: 207-662-4348
EMail: mcfarw@mmc.org
Layout table for additonal information
Responsible Party: William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier: NCT01597141     History of Changes
Other Study ID Numbers: 1R01MH065367-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 9, 2012
First Posted: May 11, 2012
Results First Submitted: October 22, 2015
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016