Clinical Trial: Tolcapone Treatment of Pathological Gambling

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Tolcapone Treatment of Pathological Gambling: An Open-Label Study

Brief Summary: The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.

Detailed Summary: The proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. The hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Sponsor: University of Chicago

Current Primary Outcome: Clinical Global Impression Scale (CGI) [ Time Frame: Visit 5 (final visit) ]

The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.


Original Primary Outcome: Clinical Global Impression Scale (CGI) [ Time Frame: Visits 1,2,3,4,5 ]

Current Secondary Outcome:

  • Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) [ Time Frame: Visit 5 (final visit) ]
    Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.
  • Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Visit 5 (final visit) ]
    Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.


Original Secondary Outcome:

  • Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) [ Time Frame: Visit 1,2,3,4,5 ]
  • Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Visits 1,2,3,4,5 ]


Information By: University of Chicago

Dates:
Date Received: June 12, 2009
Date Started: June 2009
Date Completion:
Last Updated: January 17, 2014
Last Verified: January 2014