Topiramate Trial for Compulsive Buying
- Conditions
- Compulsive Shopping
- Interventions
- Behavioral: Cognitive restructuring intervention
- Registration Number
- NCT02138058
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
It is a double blind controlled study to test the hypothesis that Topiramate is more effective than placebo in the treatment of compulsive buying, during a period of 12 weeks
- Detailed Description
Compulsive buying is a prevalent disorder with no approved pharmacological treatment. Previous reports suggest that topiramate could be useful in reducing impulsivity in pathological gambling and other impulse control disorders, as well as craving in substance addictions. The goal of this study was to investigate the effectiveness of topiramate combined with brief cognitive restructuring in treating compulsive buying, compared with just cognitive restructuring treatment+placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Match criteria for compulsive buying, according to McElroy et al. (1994), confirmed by semi-structured interview modeled after the Schedules for clinical assessment in neuropsychiatry (SCID)
- woman within fertility age have to be already practicing an acceptable contraception method and to be negative at a pregnancy test
- illiteracy
- pregnancy and breastfeeding for woman
- 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
- history of current or past Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders 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 higher than 30 at the beck depression inventory
- current participation on psychotherapy or use of pharmacological agent or experimental dispositive for compulsive buying in the past 3 months
- current use of psychotropic drugs, except benzodiazepines
- cardiovascular disease including a history of heart attack, stroke, arrhythmia, cardiac failure in the past 5 years. Uncontrolled high blood pressure.
- chronic or acute renal or liver failure, as well as Retinopathy and thyroidopathy
- a personal or family history of nephrolithiasis
- immunodeficiency
- any blood dyscrasia
- contraindication or allergy to topiramate
- history of seizures
- dont't have a phone number for contact
- live alone and don't have a person that can inform about the shopping behavior
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description topiramate Cognitive restructuring intervention a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention topiramate Topiramate a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention Placebo Cognitive restructuring intervention a 12 week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention
- Primary Outcome Measures
Name Time Method Yale-Brown Compulsive-Obsessive Scale Shopping Version 12 weeks It is a revised version of the Yale-Brown Obsessive-Compulsive Scale (YBOCS), created to assess both the cognitive and behaviour of compulsive buying as well as to rate the severity of the problem
- Secondary Outcome Measures
Name Time Method Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU) 12 weeks It was developed to provide a comprehensive side effect rating scale with well-defined and operationalized items to assess the side effects of psychopharmacological medications.
Clinical Global Impression scale (CGI) 12 weeks The CGI scale quantifies the severity of disease and the effects of treatment, as well as overall clinical improvement.
Trial Locations
- Locations (1)
Associação Viver Bem
🇧🇷São Paulo, SP, Brazil