Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

April 9, 2013 updated by: Duke University

A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Levetiracetam
Drug: Sertraline
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
Other Names:
  • Zoloft
Drug: Levetiracetam
Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
Other Names:
  • Keppra
Placebo Comparator: 2
there is no active ingredient in the pills.
Drug: Placebo
Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression-improvement (CGI-I)
Time Frame: 24 wks
24 wks

Secondary Outcome Measures

Outcome Measure
Time Frame
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time Frame: 24 wks
24 wks
Hospital Anxiety and Depression Scale
Time Frame: 24 wks
24 wks
Sheehan Disability Scale (SDS)
Time Frame: 24 wks
24 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Wei Zhang, MD, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 6, 2006

First Submitted That Met QC Criteria

March 6, 2006

First Posted (Estimate)

March 7, 2006

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe