Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 effect of Levetiracetam is more beneficial when adding with a SSRI.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam; Sertraline

Criteria

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