Conditions: Pathological Gambling
Keywords: Pathological Gambling Compulsive Gambling Gambling topiramate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: no

Brief 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

Arms:
arm 1: 25mg to 300mg daily dose arm 2: placebo equivalent tablets

Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: minimum does of 50mg/day intervention 2: matching tablet

Protocol document: