Back to resultsAugmentation Study of Levetiracetam in Obsessive Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Levetiracetam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, Anxiety, Pharmacotherapy, Sertraline, Levetiracetam
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Levetiracetam
there is no active ingredient in the pills.
Outcomes
Primary Outcome Measures
Clinical Global Impression-improvement (CGI-I)
Secondary Outcome Measures
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Hospital Anxiety and Depression Scale
Sheehan Disability Scale (SDS)
Full Information
NCT ID
NCT00299611
First Posted
March 6, 2006
Last Updated
April 9, 2013
Sponsor
Duke University
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00299611
Brief Title
Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
Official Title
A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided to terminate the study due to budget consideration
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Duke University
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, Anxiety, Pharmacotherapy, Sertraline, Levetiracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Levetiracetam
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
there is no active ingredient in the pills.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.
Primary Outcome Measure Information:
Title
Clinical Global Impression-improvement (CGI-I)
Time Frame
24 wks
Secondary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time Frame
24 wks
Title
Hospital Anxiety and Depression Scale
Time Frame
24 wks
Title
Sheehan Disability Scale (SDS)
Time Frame
24 wks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9758307
Citation
Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60.
Results Reference
background
PubMed Identifier
9393390
Citation
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.
Results Reference
background
PubMed Identifier
9429061
Citation
Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. doi: 10.1177/070674379704200902.
Results Reference
background
Links:
URL
http://dukehealth.org
Description
Related Info
URL
http://clinicaltrials.gov
Description
Related Info
URL
http://psychiatry.mc.duke.edu/Research/Research.html
Description
Related Info
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Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
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