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| Descriptive Information Fields | |||||
| Brief Title † | Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD) | ||||
| Official Title † | A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder | ||||
| Brief Summary | SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Clinical Global Impression - Improvement ≤ 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] PI-SWUR Hoarding Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Self Report Y-BOCS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
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| Condition † | Obsessive Compulsive Disorder | ||||
| Intervention † | Drug: Topiramate Drug: placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 48 | ||||
| Start Date † | January 2002 | ||||
| Completion Date | June 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00182520 | ||||
| Organization ID | 01-133 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Hamilton Health Sciences | ||||
| Collaborators †† | Janssen-Ortho Inc., Canada | ||||
| Investigators † |
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| Information Provided By | McMaster University | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | September 14, 2005 | ||||
| Last Updated Date | June 27, 2008 | ||||