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Treatment of Obsessive Compulsive Disorder in Children

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ClinicalTrials.gov Identifier: NCT00074815
Recruitment Status : Completed
First Posted : December 22, 2003
Results First Posted : February 11, 2013
Last Update Posted : July 29, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Obsessive-Compulsive Disorder
Interventions Drug: Serotonin reuptake inhibitors management
Behavioral: Cognitive behavioral therapy by a psychologist
Behavioral: Instructional cognitive behavioral therapy by a psychiatrist
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MM + CBT MM + ICBT MM Only
Hide Arm/Group Description Participants will receive medication management plus cognitive behavioral therapy with a psychologist Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist Participants will receive medication management only
Period Title: Overall Study
Started 42 40 42
Completed 37 34 30
Not Completed 5 6 12
Arm/Group Title MM + CBT MM + ICBT MM Only Total
Hide Arm/Group Description Participants will receive medication management plus cognitive behavioral therapy with a psychologist Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist Participants will receive medication management only Total of all reporting groups
Overall Number of Baseline Participants 42 40 42 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 42 participants 124 participants
<=18 years
42
 100.0%
40
 100.0%
42
 100.0%
124
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 40 participants 42 participants 124 participants
12.71  (2.88) 13.76  (2.72) 14.34  (2.51) 13.6  (2.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 42 participants 124 participants
Female
23
  54.8%
21
  52.5%
22
  52.4%
66
  53.2%
Male
19
  45.2%
19
  47.5%
20
  47.6%
58
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 40 participants 42 participants 124 participants
42 40 42 124
1.Primary Outcome
Title Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Hide Description

OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).

Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.

Time Frame Measured at baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (all included)
Arm/Group Title MM + CBT MM + ICBT MM Only
Hide Arm/Group Description:
Participants will receive medication management plus cognitive behavioral therapy with a psychologist
Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
Participants will receive medication management only
Overall Number of Participants Analyzed 42 40 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of Participants with RESPONSE
0.69
(0.54 to 0.83)
0.34
(0.18 to 0.50)
0.30
(0.15 to 0.45)
2.Secondary Outcome
Title Child Obsessive -Compulsive Impact Scale (COIS)
Hide Description [Not Specified]
Time Frame Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Child Depression Inventory
Hide Description [Not Specified]
Time Frame Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Pediatric Adverse Event Rating Scale (PAERS)
Hide Description [Not Specified]
Time Frame Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MM + CBT MM + ICBT MM Only
Hide Arm/Group Description Participants will receive medication management plus cognitive behavioral therapy with a psychologist Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist Participants will receive medication management only
All-Cause Mortality
MM + CBT MM + ICBT MM Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
MM + CBT MM + ICBT MM Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      1/40 (2.50%)      1/42 (2.38%)    
Psychiatric disorders       
Suicide Attempt that led to hospitalization and changes to medication and therapy  1 [1]  0/42 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Suicidal Thoughts due to school difficulties  2 [2]  0/42 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Suicide Attempt
2
Term from vocabulary, Suicidal Thougths
[1]
Attempt led to premature termination of treatment protocol (i.e., additional treatment outside of randomized treatment protocol). Stopped OCD treatment and began treating subject's comorbid depression.
[2]
In last protocol session, subject reported suicidal thoughts due to teasing by classmates. Given the context in which these thoughts arose (social difficulties at school), this serious adverse event was determined to be unrelated to treatment.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MM + CBT MM + ICBT MM Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/40 (0.00%)      0/42 (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: Jeffrey Sapyta, PhD
Organization: Duke University School of Medicine
Phone: 919-668-0069
EMail: jeffrey.sapyta@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00074815    
Other Study ID Numbers: Pro00008097
R01MH055121 ( U.S. NIH Grant/Contract )
DSIR 84-CTM
First Submitted: December 19, 2003
First Posted: December 22, 2003
Results First Submitted: November 15, 2012
Results First Posted: February 11, 2013
Last Update Posted: July 29, 2014