Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, Anxiety, Pharmacotherapy, Sertraline, Levetiracetam
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.
Interventions
DRUGSertraline
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
DRUGLevetiracetam
Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
DRUGPlacebo
Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.
Sponsors
UCB Pharma
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-improvement (CGI-I) | 24 wks |
Secondary
| Measure | Time frame |
|---|---|
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) | 24 wks |
| Hospital Anxiety and Depression Scale | 24 wks |
| Sheehan Disability Scale (SDS) | 24 wks |
Countries
United States
Outcome results
None listed