Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Topiramate
A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
Topiramate flexible dosage
4-session gambling cognitive restructuring
Placebo
A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.
Placebo matching tablets
4-session gambling cognitive restructuring
Interventions
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Topiramate flexible dosage
Placebo matching tablets
4-session gambling cognitive restructuring
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
21 Years
65 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Hermano Tavares
Associate Professor
Locations
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Instituto de Psiquiatria da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Other Identifiers
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1341/06
Identifier Type: -
Identifier Source: org_study_id
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