Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder|
- Clinical Global Impression-improvement (CGI-I) [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
- Hospital Anxiety and Depression Scale [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
- Sheehan Disability Scale (SDS) [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
Other Name: ZoloftDrug: Levetiracetam
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.
This is an investigator-initiated, single-site study, consisting of two phases: 8 weeks of open-label treatment with sertraline (50mg-150mg/day) in patients iwth OCD.At week 8, those who have failed to achieve remission will be continued on sertraline and will be randomized to receive Levetiracetam (500mg-2000mg/day) or Placebo for 8 weeks.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Wei Zhang, MD, PhD||Duke University|