Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00299611
• Other study ID #: Pro00008596
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 6, 2006
• Last updated: April 9, 2013
• Start date: November 2005
• Est. completion date: April 2008

Study information

• Verified date: June 2010
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Sertraline
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
• Levetiracetam
Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
• Placebo
Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60. Review. — View 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. Review. — View Citation

Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-improvement (CGI-I)		24 wks	Yes
Secondary	Yale-Brown Obsessive-Compulsive Scale (YBOCS)		24 wks	Yes
Secondary	Hospital Anxiety and Depression Scale		24 wks	Yes
Secondary	Sheehan Disability Scale (SDS)		24 wks	Yes

External Links

•   Link
•   Link