Early Detection and Intervention for the Prevention of Psychosis (EDIPP)

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT00531518
First received: September 18, 2007
Last updated: July 6, 2016
Last verified: July 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Schizophrenia
Bipolar Disorder
Depression
Psychotic Disorders
Interventions: Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Behavioral: Psychoeducational multifamily group treatment
Behavioral: Supported employment and education

  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
Control Group This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
Family-aided Assertive Community Treatment

This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .

aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations

Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work

Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.


Participant Flow:   Overall Study
    Control Group     Family-aided Assertive Community Treatment  
STARTED     87     205  
COMPLETED     55     134  
NOT COMPLETED     32     71  



  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.
All eligible participants (n=292) were entered into the outcome analysis. This was an intent-to-treat study and statistical analysis.

Reporting Groups
  Description
Control Group This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
Experimental Intervention

This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .

aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations

Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work

Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.

Total Total of all reporting groups

Baseline Measures
    Control Group     Experimental Intervention     Total  
Number of Participants  
[units: participants]
  87     205     292  
Age  
[units: years]
Mean (Standard Deviation)
  16.23  (3.18)     16.40  (3.30)     16.35  (3.26)  
Gender  
[units: participants]
     
Female     26     89     115  
Male     61     116     177  
Region of Enrollment  
[units: participants]
     
United States     87     205     292  
Psychotic symptoms [1]
[units: units on a scale]
Mean (Standard Deviation)
  4.15  (1.76)     11.99  (3.42)     9.65  (4.69)  
[1] Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.



  Outcome Measures

1.  Primary:   Psychotic Symptoms   [ Time Frame: two years ]


  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:

Responsible Party: William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00531518     History of Changes
Other Study ID Numbers: 58920
RWJF #58920 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
Study First Received: September 18, 2007
Results First Received: January 20, 2016
Last Updated: July 6, 2016
Health Authority: United States: Institutional Review Board