OBJECTIVE: Several open-label and double-blind studies have suggested that selective serotonin reuptake inhibitors may be useful in the treatment of pathological gambling. The purpose of this study was to evaluate the efficacy of sertraline in the treatment of pathological gambling. METHOD:Sixty patients meeting the DSM-IV criteria for pathological gambling were treated for 6 months in a double-blind, flexible-dose, placebo-controlled study of sertraline 50 to 150 mg/day. Data were collected from November 1998 to January 2001. The primary outcome measure assessing change in clinical status was the responder rate with respect to the Criteria for Control of Pathological Gambling Questionnaire (CCPGQ). Secondary measures included the Clinical Global Impressions scale (CGI) (Severity of Illness and Improvement subscales), and Visual Analogue Scales assessing gambling frequency, severity, amount, and improvement. Concomitant medication and psychotherapy were not allowed during the study. RESULTS: At the end of the study, 23 sertraline-treated subjects (74%) and 21 placebo-treated subjects (72%) were considered as responders on the CCPGQ (p = .9). Similar results were obtained when the CGI-Improvement scale limited to symptoms of pathological gambling was used as an outcome measure. Sertraline was well tolerated throughout the study. CONCLUSION:Sertraline was not statistically significantly superior to placebo in the overall sample. The power of the study was limited by the high placebo-response rate and the small sample size.
RCT Entities:
OBJECTIVE: Several open-label and double-blind studies have suggested that selective serotonin reuptake inhibitors may be useful in the treatment of pathological gambling. The purpose of this study was to evaluate the efficacy of sertraline in the treatment of pathological gambling. METHOD: Sixty patients meeting the DSM-IV criteria for pathological gambling were treated for 6 months in a double-blind, flexible-dose, placebo-controlled study of sertraline 50 to 150 mg/day. Data were collected from November 1998 to January 2001. The primary outcome measure assessing change in clinical status was the responder rate with respect to the Criteria for Control of Pathological Gambling Questionnaire (CCPGQ). Secondary measures included the Clinical Global Impressions scale (CGI) (Severity of Illness and Improvement subscales), and Visual Analogue Scales assessing gambling frequency, severity, amount, and improvement. Concomitant medication and psychotherapy were not allowed during the study. RESULTS: At the end of the study, 23 sertraline-treated subjects (74%) and 21 placebo-treated subjects (72%) were considered as responders on the CCPGQ (p = .9). Similar results were obtained when the CGI-Improvement scale limited to symptoms of pathological gambling was used as an outcome measure. Sertraline was well tolerated throughout the study. CONCLUSION:Sertraline was not statistically significantly superior to placebo in the overall sample. The power of the study was limited by the high placebo-response rate and the small sample size.