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Treatment of Obsessive Compulsive Disorder in Children

This study is currently recruiting participants.
Study NCT00074815.   Last updated on September 17, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Treatment of Obsessive Compulsive Disorder in Children
Official Title  Treatment of Pediatric OCD for SRI Partial Responders
Brief Summary

This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.

Detailed Description

The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT), yet this recommendation is seldom followed. This study will contrast two CBT augmentation strategies to continued medication management alone: CBT administered by a psychologist and instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication management.

All patients in the trial will be eligible to receive a full course of CBT by study end. Participants in this study will be randomly assigned to receive CBT, I-CBT or continued medication management. All participants will continue their SRI treatment for 12 weeks. After the 12-week treatment period, participants who received I-CBT or medication management alone and who remain symptomatic will be given CBT as will participants who are asymptomatic but relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Child Obsessive -Compulsive Impact Scale (COIS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
Child Depression Inventory [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
Pediatric Adverse Event Rating Scale (PAERS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
Condition  Obsessive-Compulsive Disorder
Intervention  Drug: Serotonin reuptake inhibitors management
Behavioral: Cognitive behavioral therapy by a psychologist
Behavioral: Instructional cognitive behavioral therapy by a psychiatrist
MEDLINE PMIDs
Links Duke Program in Child Affective and Anxiety Disorders This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  150
Start Date  September 2003
Completion Date September 2009
Eligibility Criteria 

Inclusion Criteria:

  • DSM-IV Diagnosis of obsessive compulsive disorder
  • CYBOCS total score greater than 16

Exclusion Criteria:

  • Other primary or co-primary psychiatric disorder
  • Pervasive developmental disorder or disorders, including Asperger's Syndrome
  • Thought disorder
  • Prior failed trial of cognitive-behavioral therapy
  • Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
  • Mental retardation
  • Pregnancy
Gender Both
Ages 7 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00074815
Organization ID R01 MH55121
Secondary IDs †† DSIR 84-CTM
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     John S March, MD MPH     Duke University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date September 2008
First Received Date  December 19, 2003
Last Updated Date September 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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