Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Obsessive-Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT00299611

Run by

Duke University

People needed

12

Starts

2005-11-01

Expected to finish

2008-04-01

Last updated by the study team

2013-04-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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