This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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. There are few trials using mood stabilizers for the treatment of pathological gambling. This is a 15-week, outpatient, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of topiramate in 24 subjects who meet DSM-IV criteria for pathological gambling and also do not have a concurrent DSM-IV diagnosis or symptomatology that would preclude their participation in this study. After the initial assessment and consent to participate, the patient will begin treatment for pathological gambling using topiramate. The starting dose will be 25mg/day, and we propose to flexibly titrate that dose up to 400mg, depending on the participant's tolerability, throughout the 15-week study. Patients will return for appointments with the medication psychiatrist in weeks 1, 2, 4, 6, 8, 10, 12, 14, and 15. During these appointments, patients will be assessed for complicance with medication, side effects, adverse events, and no use of other concurrent medications. In addition, patients be rated on the Gambling Symptom Severity Scale, the PG-YBCS, the CGI-S and the CGI-I. At weeks 1 and 14, patients will also be rated on the Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale, and the Barratt Impulsiveness Scale. In this way, the efficacy of topiramate in pathological gambling will be evaluated. Hypothesis: It is hypothesized that there will be an improvement in gambling behavior and urge after 15 weeks of treatment with topiramate as compared to placebo. This will be measured through the Pathological Gambling - Yale Brown Obsessive Compulsive Scale and the Gambling Symptom Assessment Scale.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000071-43
Application #
7380562
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-17
Project End
2007-02-28
Budget Start
2006-04-17
Budget End
2007-02-28
Support Year
43
Fiscal Year
2006
Total Cost
$33,780
Indirect Cost
Name
Mount Sinai School of Medicine
Department
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
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