NCT00245583

Topiramate in the Treatment of Pathological Gambling

Topiramate in the Treatment of Pathological Gambling: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of topiramate in the treatment of pathological gambling. Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal, familial, financial, social, and occupational impairments. In PG, the patient experiences a progressive inability to resist impulses to gamble, and gambling significantly disrupt the patient's functioning in the personal, familial, and/or vocational spheres. Topiramate has shown preliminary evidence of efficacy in some impulse control disorders.

Detailed description

This is a 14-week, outpatient, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of topiramate in subjects with pathological gambling. After giving informed consent, subjects who meet all the inclusion and exclusion criteria may be enrolled. The study will consist of three phases: * Washout/Screening Phase (up to 28 days prior to randomization or longer for those medications requiring a longer washout period; * Double-Blind Phase (Titration: up to 6 weeks; Maintenance: 8 weeks); and * Taper Phase (approximately 1 week). The study medication will be titrated to 300 mg/day or the subject's maximum tolerated dose (MTD). Subjects must reach a minimum dose of 50 mg/day by Week 2. The taper phase will last approximately one week where subjects gradually reduce their medication until they are no longer taking study medication. Patient may also give an optional blood sample for pharmacogenomic testing

Conditions

• Pathological Gambling

Interventions

Type	Name	Description
DRUG	Topiramate	minimum does of 50mg/day
DRUG	Placebo	matching tablet

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2005-10-28
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

1 site across 1 country: United States