Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Obsessive Compulsive Disorder in Children

This study has been completed.
Sponsor:
Collaborator:
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00074815     History of Changes
Other Study ID Numbers: Pro00008097, R01MH055121, 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