Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 8, 2008 | ||||||||
| Last Updated Date | August 22, 2012 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Regional concentration of glutamate and glutamine in brain, as measured by MRSI [ Time Frame: 14 weeks ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00748761 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Overall score on child Yale-Brown Obsessive-Compulsive Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder | ||||||||
| Official Title ICMJE | Cognitive-Behavioral Therapy & Glutametergic Neurometabolites in Pediatric OCD | ||||||||
| Brief Summary | This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment. |
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| Detailed Description | Obsessive-compulsive disorder (OCD) afflicts 2% to 4% of children and adolescents, who suffer from persistent, unwanted thoughts and repetitive behaviors. One of the most effective treatments of OCD is cognitive behavioral therapy (CBT), yet researchers do not know how CBT affects the brain. In this study, brain scans will be performed to determine concentrations of several neurometabolites, which are chemicals involved in providing energy to the brain. Of particular importance are the neurometabolites glutamine and glutamate, which, in addition to providing energy to the brain, are among the most common excitatory neurotransmitters. Disruption of glutamine and glutamate is thought to be related to OCD. By examining where in the brain levels of glutamate and glutamine change, researchers will attempt to determine whether CBT modifies brain activity, whether a circuit targeted by researchers is affected by CBT, and how brain activity in people with OCD differs from that of people without the disorder in terms of the targeted circuit. Children and adolescents ages 8 through 17 with OCD will be randomly assigned to either receive a 12-week CBT intervention or be placed on a waiting list for 8 weeks before receiving the 12-week intervention. A group of non-OCD participants in the same age group will be used as a control. All groups will undergo magnetic resonance spectroscopic imaging (MRSI), which will measure the concentrations of neurometabolites in multiple brain regions. The control group and the group initially given the CBT intervention will be scanned upon entry of the study and after 12 weeks. The group initially placed on a waiting list will be scanned three times: once upon entry, once after the 8-week waiting period, and once after the 12-week CBT intervention. To determine which participants are benefitting from the treatment, the Yale-Brown Obsessive-Compulsive Scale and other clinical and neurocognitive measures will be administered concurrently with each brain scan. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obsessive-Compulsive Disorder | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 108 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00748761 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH081864, DDTR B2-NDO | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Joseph O'Neill, National Institute of Mental Health (NIMH) | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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