Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Levetiracetam

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

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

Levetiracetam

Intervention Type DRUG

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

2

there is no active ingredient in the pills.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Sertraline

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

Intervention Type DRUG

Levetiracetam

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Zoloft Keppra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No