Status:
COMPLETED
Topiramate Trial for Pathological Gamblers
Lead Sponsor:
University of Sao Paulo
Conditions:
Pathological Gambling
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
Objectives: Pathological gambling (PG) is a prevalent disorder with no approved pharmacological treatment. Previous reports suggest that topiramate could be useful in reducing impulsivity in PG, and c...
Eligibility Criteria
Inclusion
- current Diagnostic and Statistical Manual Fourth Edition Text Revised (DSM-IV-TR) diagnosis of pathological gambling
- a betting frequency of at least once a week in the last 30 days
- women within fertility age had to be already practicing an acceptable contraception method and to be negative at a pregnancy test.
Exclusion
- illiteracy
- breastfeeding for women
- previous history of alcohol abuse/dependence with current elevation of liver enzymes, or a present diagnosis of alcohol abuse/dependence
- past or current drug abuse/dependence, except for nicotine dependence
- history of current or past DSM-IV-TR diagnosis of bipolar disorder, schizophrenia, psychosis or any neuropsychiatric condition causing cognitive impairment
- a history of suicide attempt or acute suicide risk
- severe depression indicated by a score equal to or higher than 30 at the Beck Depression Inventory
- current participation in psychotherapy for pathological gambling, including Gamblers Anonymous in the past 3 months
- current use of mood stabilizers, antidepressants, antipsychotics, except occasional use of benzodiazepines
- cardiovascular disease including a history of heart attack, stroke, arrhythmia, cardiac failure in the past 5 years
- chronic or acute renal and liver failure
- a personal or family history of nephrolithiasis
- immunodeficiency
- any blood dyscrasia.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01843699
Start Date
June 1 2009
Last Update
May 3 2013
Active Locations (1)
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1
Instituto de Psiquiatria da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403-010