Topiramate Trial for Compulsive Buying (TFO)
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ClinicalTrials.gov Identifier: NCT02138058 |
Recruitment Status :
Completed
First Posted : May 14, 2014
Last Update Posted : May 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Compulsive Shopping | Drug: Topiramate Behavioral: Cognitive restructuring intervention | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double Blind Controlled Trial of Topiramate for Compulsive Buying |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
a 12 week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention
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Behavioral: Cognitive restructuring intervention
4 sessions of a manualized cognitive restructuring intervention for compulsive buying
Other Name: behavioral |
Experimental: topiramate
a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention
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Drug: Topiramate Behavioral: Cognitive restructuring intervention 4 sessions of a manualized cognitive restructuring intervention for compulsive buying
Other Name: behavioral |
- Yale-Brown Compulsive-Obsessive Scale Shopping Version [ Time Frame: 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
- Clinical Global Impression scale (CGI) [ Time Frame: 12 weeks ]The CGI scale quantifies the severity of disease and the effects of treatment, as well as overall clinical improvement.
- Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU) [ Time Frame: 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.
- Social adjustment [ Time Frame: 12 weeks ]The social Adjustment scale (SAS) is a self-report scale that assesses seven specific areas: work, social, life and leisure, extended family relationship, marital relationship, relationship with offsprings, domestic life and financial situation

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138058
Brazil | |
Associação Viver Bem | |
São Paulo, SP, Brazil, 05404-010 |
Principal Investigator: | Hermano Tavares, Professor | associate |
Responsible Party: | Hermano Tavares, Associate professor, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT02138058 |
Other Study ID Numbers: |
Topiramate for oniomania |
First Posted: | May 14, 2014 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | December 2015 |
compulsive buying, compulsive shopping, topiramate |
Topiramate Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs |