Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Phase 2

Terminated

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Placebo; Drug: Sertraline; Drug: Levetiracetam

• Registration Number: NCT00299611
• Lead Sponsor: Duke University

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

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 to achieve remission will be continued on sertraline and will be randomized to receive Levetiracetam (500mg-2000mg/day) or Placebo for 8 weeks.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-07
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2010-06
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levetiracetam	Levetiracetam
2	Placebo	there is no active ingredient in the pills.
1	Sertraline	Levetiracetam

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression-improvement (CGI-I)	24 wks

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	24 wks
Sheehan Disability Scale (SDS)	24 wks
Yale-Brown Obsessive-Compulsive Scale (YBOCS)	24 wks

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States