Clinical trial NCT00299611: Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
Official title: A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Anxiety
Pharmacotherapy
Sertraline
Levetiracetam
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2006-03-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Global Impression-improvement (CGI-I)
timeFrame: 24 wks
Secondary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale (YBOCS)
timeFrame: 24 wks
measure: Hospital Anxiety and Depression Scale
timeFrame: 24 wks
measure: Sheehan Disability Scale (SDS)
timeFrame: 24 wks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60.
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.
citation: Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. doi: 10.1177/070674379704200902.