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

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ClinicalTrials.gov Identifier: NCT00531518
Recruitment Status : Completed
First Posted : September 19, 2007
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
Enrollment 292
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Family-aided Assertive Community Treatment
Hide Arm/Group Description This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.

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.

Period Title: Overall Study
Started 87 205
Completed 55 134
Not Completed 32 71
Arm/Group Title Control Group Experimental Intervention Total
Hide Arm/Group Description This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.

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 of all reporting groups
Overall Number of Baseline Participants 87 205 292
Hide Baseline Analysis Population Description
All eligible participants (n=292) were entered into the outcome analysis. This was an intent-to-treat study and statistical analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 205 participants 292 participants
16.23  (3.18) 16.40  (3.30) 16.35  (3.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 205 participants 292 participants
Female
26
  29.9%
89
  43.4%
115
  39.4%
Male
61
  70.1%
116
  56.6%
177
  60.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 87 participants 205 participants 292 participants
87 205 292
Psychotic symptoms   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 87 participants 205 participants 292 participants
4.15  (1.76) 11.99  (3.42) 9.65  (4.69)
[1]
Measure Description: 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.
1.Primary Outcome
Title Psychotic Symptoms
Hide Description 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.
Time Frame two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Family-aided Assertive Community Treatment
Hide Arm/Group Description:
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.

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.

Overall Number of Participants Analyzed 87 205
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.2  (1.0) 6.7  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Family-aided Assertive Community Treatment
Comments The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0034
Comments The final analysis included adjstment for site and baseline sum psychotic symptom score.
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Over 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Family-aided Assertive Community Treatment
Hide Arm/Group Description This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.

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.

All-Cause Mortality
Control Group Family-aided Assertive Community Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Family-aided Assertive Community Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/87 (1.15%)      0/205 (0.00%)    
Psychiatric disorders     
suicide   1/87 (1.15%)  1 0/205 (0.00%)  0
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%
Control Group Family-aided Assertive Community Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/87 (21.84%)      51/205 (24.88%)    
Psychiatric disorders     
Negative events  [1]  19/87 (21.84%)  19 51/205 (24.88%)  51
Indicates events were collected by systematic assessment
[1]
"Negative events" is the measure that includes hospitalizations, incarcerations, assaults, suicides and suicide attempts. It is the sum of such events within each experimental treatment condition.
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: NCT00531518     History of Changes
Other Study ID Numbers: 58920
RWJF #58920 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
First Submitted: September 18, 2007
First Posted: September 19, 2007
Results First Submitted: January 20, 2016
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016