Topiramate Trial for Compulsive Buying
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Compulsive Shopping
Intervention: Topiramate (Drug); placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): Hermano Tavares, Professor, Principal Investigator, Affiliation: associate
Overall contact: Hermano Tavares, Professor, Phone: +55-11-26617805, Email: hermanot@uol.com.br
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
Clinical Details
Official title: Double Blind Controlled Trial of Topiramate for Compulsive Buying
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Yale-Brown Compulsive-Obsessive Scale Shopping Version
Secondary outcome: Clinical Global Impression scale (CGI)Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU)
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hermano Tavares, Professor, Phone: +55-11-26617805, Email: hermanot@uol.com.br
Associação Viver Bem, São Paulo, SP 05404-010, Brazil; Not yet recruiting Hermano Tavares, Professor, Principal Investigator
Additional Information
association
Starting date: January 2015
Last updated: May 12, 2014
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