Status:
TERMINATED
Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
Lead Sponsor:
Duke University
Collaborating Sponsors:
UCB Pharma
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- ages 18-65
- primary diagnosis of OCD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of at least 16 or greater on screening
- Ability to provide written consent form
Exclusion
- Any primary DSM-IV Axis I disorder other than OCD
- Substance abuse during the last 6 months
- A clinically unstable medical condition or clinically significant laboratory abnormalities
- Suicidal risk or serious suicidal attept during the last year
- Concurrent use of psychotropic medication including benzodiazepines, barbituates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects
- Recent (within the last 3 months) initiation of cognitive behavioral therapy
- Failure of previous trial of levetiracetam at 2000 mg/day
- Pregnancy or lactation
- Women of childbearing potential who are unwilling to practice an acceptable method of contraception
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00299611
Start Date
November 1 2005
End Date
April 1 2008
Last Update
April 11 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710