Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Phase 3TerminatedNCT00299611

Duke University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

SertralineDRUG

Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.

LevetiracetamDRUG

Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.

PlaceboDRUG

Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Clinical Global Impression-improvement (CGI-I)

Time frame: 24 wks

Secondary Outcomes

Yale-Brown Obsessive-Compulsive Scale (YBOCS)

Time frame: 24 wks

Hospital Anxiety and Depression Scale

Time frame: 24 wks

Sheehan Disability Scale (SDS)

Time frame: 24 wks

Data from ClinicalTrials.gov

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