Psychosis: Early Detection, Intervention and Prevention (EDIP)

This study has been completed.
Sponsor:
Collaborators:
Columbia University
Harvard University
University of California, Irvine
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT01597141
First received: May 9, 2012
Last updated: January 7, 2016
Last verified: January 2016
Results First Received: October 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Family-aided ACT

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.

Enhanced Treatment

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


Participant Flow:   Overall Study
    Family-aided ACT     Enhanced Treatment  
STARTED     50     50  
COMPLETED     50     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Family-aided ACT

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.

Enhanced Treatment

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 Total of all reporting groups

Baseline Measures
    Family-aided ACT     Enhanced Treatment     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: years]
Mean (Standard Deviation)
  16.48  (3.07)     16.12  (2.75)     16.3  (2.9)  
Gender  
[units: participants]
     
Female     24     24     48  
Male     26     26     52  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic     0     4     4  
Non-Hispanic     50     46     96  
Region of Enrollment  
[units: participants]
     
United States     50     50     100  
Global Assessment of Functioning (GAF) [1]
[units: units on GAF scale]
Mean (Standard Deviation)
  40.16  (13.93)     36.39  (10.35)     39.7  (12.1)  
[1] 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.



  Outcome Measures
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1.  Primary:   Onset of Psychosis   [ Time Frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months ]

2.  Secondary:   Functioning   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: William R. McFarlane, M.D.
Organization: Maine Medical Center Research Institute
phone: 207-662-4348
e-mail: mcfarw@mmc.org


Publications of Results:
Other Publications:

Responsible Party: William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier: NCT01597141     History of Changes
Other Study ID Numbers: 1R01MH065367-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: May 9, 2012
Results First Received: October 22, 2015
Last Updated: January 7, 2016
Health Authority: United States: Federal Government