Topiramate Trial for Compulsive Buying

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double Blind Controlled Trial of Topiramate for Compulsive Buying

Conditions
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Compulsive Shopping

Intervention / Treatment
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* Drug: Topiramate
* Behavioral: Cognitive restructuring intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>a 12 week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention | Behavioral: Cognitive restructuring intervention<br>* 4 sessions of a manualized cognitive restructuring intervention for compulsive buying<br>* Other names: behavioral;|
| Experimental: topiramate<br>a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention | Drug: Topiramate<br> <br> Behavioral: Cognitive restructuring intervention<br>* 4 sessions of a manualized cognitive restructuring intervention for compulsive buying<br>* Other names: behavioral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Compulsive-Obsessive Scale Shopping Version | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression scale (CGI) | The CGI scale quantifies the severity of disease and the effects of treatment, as well as overall clinical improvement. | 12 weeks | 
| Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU) | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compulsive buying, compulsive shopping, topiramate