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Treatment of Obsessive Compulsive Disorder in Children

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00074815
First received: December 19, 2003
Last updated: July 23, 2014
Last verified: November 2012
Results First Received: November 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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

  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
MM + CBT Participants will receive medication management plus cognitive behavioral therapy with a psychologist
MM + ICBT Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
MM Only Participants will receive medication management only

Participant Flow:   Overall Study
    MM + CBT   MM + ICBT   MM Only
STARTED   42   40   42 
COMPLETED   37   34   30 
NOT COMPLETED   5   6   12 



  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.
No text entered.

Reporting Groups
  Description
MM + CBT Participants will receive medication management plus cognitive behavioral therapy with a psychologist
MM + ICBT Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
MM Only Participants will receive medication management only
Total Total of all reporting groups

Baseline Measures
   MM + CBT   MM + ICBT   MM Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   40   42   124 
Age 
[Units: Participants]
       
<=18 years   42   40   42   124 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.71  (2.88)   13.76  (2.72)   14.34  (2.51)   13.6  (2.77) 
Gender 
[Units: Participants]
       
Female   23   21   22   66 
Male   19   19   20   58 
Region of Enrollment 
[Units: Participants]
       
United States   42   40   42   124 


  Outcome Measures

1.  Primary:   Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)   [ Time Frame: Measured at baseline and Week 12. ]

2.  Secondary:   Child Obsessive -Compulsive Impact Scale (COIS)   [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Child Depression Inventory   [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Pediatric Adverse Event Rating Scale (PAERS)   [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Jeffrey Sapyta, PhD
Organization: Duke University School of Medicine
phone: 919-668-0069
e-mail: jeffrey.sapyta@duke.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00074815     History of Changes
Other Study ID Numbers: Pro00008097
R01MH055121 ( US NIH Grant/Contract Award Number )
DSIR 84-CTM
Study First Received: December 19, 2003
Results First Received: November 15, 2012
Last Updated: July 23, 2014
Health Authority: United States: Federal Government