Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT00299611|
Recruitment Status : Terminated (Sponsor decided to terminate the study due to budget consideration)
First Posted : March 7, 2006
Last Update Posted : April 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: Sertraline Drug: Levetiracetam Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||April 2008|
Active Comparator: 1
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
Other Name: Zoloft
Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
Other Name: Keppra
Placebo Comparator: 2
there is no active ingredient in the pills.
Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.
- Clinical Global Impression-improvement (CGI-I) [ Time Frame: 24 wks ]
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) [ Time Frame: 24 wks ]
- Hospital Anxiety and Depression Scale [ Time Frame: 24 wks ]
- Sheehan Disability Scale (SDS) [ Time Frame: 24 wks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299611
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Wei Zhang, MD, PhD||Duke University|