Clinical Trial: Efficacy and Safety Study of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-<

Brief Summary: This study is to assess the efficacy and safety of two doses of ondansetron (0.5 mg and 0.75 mg) relative to placebo when administered twice daily as adjunctive therapy for adult patients with Obsessive-Compulsive Disorder (OCD) who have not adequately responded to treatment with a serotonin reuptake inhibitor (SRI).

Detailed Summary:

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study.

A sufficient number of patients will be screened to obtain approximately 150 patients randomized to the double-blind portion of the study. This study will consist of at least 6 weeks of retrospectively documented SRI treatment (prior to screening), 6 weeks of prospective SRI treatment after screening (run-in) but prior to randomization, and 12 weeks of double-blind treatment with study drug (ondansetron 0.5 mg twice a day, ondansetron 0.75 mg twice a day or placebo twice a day).

All patients will have been maintained on a single SRI at the same dose throughout the retrospective 6-week period and will continue the same SRI at the same dose throughout the run-in and double-blind treatment periods.

The 12-week randomized, double-blind, placebo-controlled, parallel-group study will be the "core period" for purposes of efficacy and short-term safety assessment. Patients completing all 12 weeks of the core period will be offered an opportunity to participate in an "extension period" where they will continue to receive treatment for up to 30 months following the core period.

Treatment assignment in the extension period will be as follows: responders will continue on the same double-blind treatment to which they were assigned in the core period (ondansetron 0.5 mg twice a day, ondansetron 0.75 mg twice a day, or placebo twice a day); non-responders will be reassigned to continuing treatment according to their prior treatment assignment in the core period (those who received placebo will be assigned to ondansetron 0.5 mg twice a day, those who received ondansetron 0.5 mg twice a day will be assigned to ondansetron 0.75 mg t
Sponsor: Transcept Pharmaceuticals

Current Primary Outcome:

  • Core Period: Change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total at Month 3 score [ Time Frame: Day -1 (baseline), Month 3 ]
  • Extension Period: Participants with Safety Adverse Experiences [ Time Frame: up to Month 33 ]


Original Primary Outcome: Change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score [ Time Frame: Baseline, Week 12 ]

Current Secondary Outcome:

  • Core Period: Participants Considered Responders as Measured by the Clinical Global Impression-Improvement (CGI-I) Score [ Time Frame: Month 3 ]
  • Core Period: Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Month 3 [ Time Frame: Day -1 (baseline), Month 3 ]
  • Core Period: Change from Baseline in the Sheehan Disability Scale (SDS) Score at Month 3 [ Time Frame: Day -1 (baseline), Month 3 ]


Original Secondary Outcome:

  • Participants Considered Responders as Measured by the Clinical Global Impression-Improvement (CGI-I) Score [ Time Frame: Week 12 ]
  • Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in the Sheehan Disability Scale (SDS) Score [ Time Frame: Baseline, Week 12 ]


Information By: Transcept Pharmaceuticals

Dates:
Date Received: January 10, 2011
Date Started: January 2011
Date Completion: September 2015
Last Updated: January 16, 2013
Last Verified: January 2013