Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

A Double-Blind 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.

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.

Inclusion Criteria:

• 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 Criteria:

• 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