Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder - Full Text View

Sponsors and Collaborators:	Duke University UCB
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00299611

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 II Phase III

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

Drug Information available for: Sertraline hydrochloride Sertraline Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder

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
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Levetiracetam	Drug: Sertraline Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks. Drug: Levetiracetam Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
2: Placebo Comparator 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

Investigators

Principal Investigator:

Wei Zhang, MD, PhD

Duke University

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60. Review.

Sasson Y, Zohar J, Chopra M, Lustig M, Iancu I, Hendler T. Epidemiology of obsessive-compulsive disorder: a world view. J Clin Psychiatry. 1997;58 Suppl 12:7-10. Review.

Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. Review.

Responsible Party:	DUMC ( Wei Zhang/ Director of Anxiety and Traumatic Stress Program )
Study ID Numbers:	7242
Study First Received:	March 6, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00299611
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

OCD
Anxiety
Pharmacotherapy
Sertraline
Levetiracetam

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Piracetam
Sertraline

Etiracetam
Serotonin
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Protective Agents
Neuroprotective Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Anticonvulsants
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009