Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

This study has been terminated.
(Sponsor decided to terminate the study due to budget consideration)
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00299611
First received: March 6, 2006
Last updated: April 9, 2013
Last verified: June 2010
  Purpose

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 Intervention Phase
Obsessive-Compulsive Disorder
Drug: Sertraline
Drug: Levetiracetam
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clinical Global Impression-improvement (CGI-I) [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale (YBOCS) [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
  • Sheehan Disability Scale (SDS) [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: November 2005
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Levetiracetam
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299611

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
UCB, Inc.
Investigators
Principal Investigator: Wei Zhang, MD, PhD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Wei Zhang/ Director of Anxiety and Traumatic Stress Program, DUMC
ClinicalTrials.gov Identifier: NCT00299611     History of Changes
Other Study ID Numbers: Pro00008596
Study First Received: March 6, 2006
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
OCD
Anxiety
Pharmacotherapy
Sertraline
Levetiracetam

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Etiracetam
Piracetam
Sertraline
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014