Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
This study has been terminated.
(Sponsor decided to terminate the study due to budget consideration)
Sponsor:
Duke University
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
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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 Anxiety Disorders Mental 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 May 23, 2013