HYPOTHESIS: PRIMARY: Augmentation of selective serotonin reuptake inhibitor (SSRI) treatment of Obsessive-Compulsive Disorder w/ondansetron at 3 mg daily for 6 weeks will reduce OCD symptoms significantly more than placebo augmentation. SUBSIDIARY: 1) Augmentation w/ondansetron at 3 mg daily for 11 weeks will reduce OCD symptoms significantly more than augmentation for 6 weeks in the same patients (Shorter vs Longer Treatment). 2) Augmentation w/ondansetron at 6 mg daily for 8 weeks will reduce OCD symptoms significantly more than placebo augmentation for 8 weeks in the same patients (Higher Dose vs Placebo). 3) Augmentation w/ondansetron at 6 mg daily will reduce OCD symptoms significantly more than augmentation at 3 mg daily (Higher Dose vs Lower Dose). 4) Withdrawal of ondansetron treatment at 3 mg daily will be associated w/a statistically significant increase in symptoms (Withdrawal Comparison).
SPECIFIC AIMS : 1) Recruit 30 patients w/a DSM-IV diagnosis of OCD into a randomized trial of SSRI plus ondansetron vs SSRI plus placebo. 2) Monitor patient symptoms using weekly Yale Brown Obsessive Compulsive Scale (YBOCS) total score, YBOCS Clinical Global Impression (CGI) and a patient self-rating scales (PSRS, TOUCS). 3) Comparatively analyze treatment conditions for statistically significant changes in YBOCS, patient self-rating scores, and average CGI rating over the course of an 18 week trial.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-40
Application #
6409591
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Type
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37203
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