Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299611
Recruitment Status : Terminated (Sponsor decided to terminate the study due to budget consideration)
First Posted : March 7, 2006
Last Update Posted : April 11, 2013
UCB Pharma
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: Sertraline Drug: Levetiracetam Drug: Placebo Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder
Study Start Date : November 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: Sertraline
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
Other Name: Zoloft

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

Primary Outcome Measures :
  1. Clinical Global Impression-improvement (CGI-I) [ Time Frame: 24 wks ]

Secondary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale (YBOCS) [ Time Frame: 24 wks ]
  2. Hospital Anxiety and Depression Scale [ Time Frame: 24 wks ]
  3. Sheehan Disability Scale (SDS) [ Time Frame: 24 wks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299611

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
UCB Pharma
Principal Investigator: Wei Zhang, MD, PhD Duke University

Additional Information:
Responsible Party: Wei Zhang/ Director of Anxiety and Traumatic Stress Program, DUMC Identifier: NCT00299611     History of Changes
Other Study ID Numbers: Pro00008596
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: June 2010

Keywords provided by Duke University:

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Nootropic Agents
Neuroprotective Agents
Protective Agents