Clinical trial NCT02138058: Topiramate Trial for Compulsive Buying
Official title: Double Blind Controlled Trial of Topiramate for Compulsive Buying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Compulsive Shopping
Keywords: compulsive buying, compulsive shopping, topiramate
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Yale-Brown Compulsive-Obsessive Scale Shopping Version
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Global Impression scale (CGI)
timeFrame: 12 weeks
measure: Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU)
timeFrame: 12 weeks
Other outcomes:
measure: Social adjustment
timeFrame: 12 weeks
Locations:
city: São Paulo
country: Brazil
facility: Associação Viver Bem
state: SP
Study officials:
affiliation: associate
name: Hermano Tavares, Professor
role: PRINCIPAL_INVESTIGATOR
References: