Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

• 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 ]

• Yale-Brown Obsessive-Compulsive Scale (YBOCS)
• Hospital Anxiety and Depression Scale
• Sheehan Disability Scale (SDS)

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.

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.

• 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
• Drug: Placebo
  Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.

• Active Comparator: 1
  Levetiracetam
  Interventions:

  • Drug: Sertraline
  • Drug: Levetiracetam
• Placebo Comparator: 2
  there is no active ingredient in the pills.
  Intervention: Drug: Placebo

• Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60. Review.
• 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. Review.
• Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. Review.

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