Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Sertraline
* Drug: Levetiracetam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Levetiracetam | Drug: Sertraline<br>* Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.<br>* Other names: Zoloft;Drug: Levetiracetam<br>* Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.<br>* Other names: Keppra;|
| Placebo Comparator: 2<br>there is no active ingredient in the pills. | Drug: Placebo<br>* Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-improvement (CGI-I) |  | 24 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) |  | 24 wks | 
| Hospital Anxiety and Depression Scale |  | 24 wks | 
| Sheehan Disability Scale (SDS) |  | 24 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, Anxiety, Pharmacotherapy, Sertraline, Levetiracetam