Topiramate Trial for Compulsive Buying | Clinical Trial

Key information

Conditions

Compulsive Shopping

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Associação Viver Bem

São Paulo, 05404-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

Cognitive restructuring intervention

Behavioral

4 sessions of a manualized cognitive restructuring intervention for compulsive buying

Other names: behavioral

Primary outcomes

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

Secondary outcomes

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.

Other outcomes

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Double Blind Controlled Trial of Topiramate for Compulsive Buying

Acronym: TFO

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 14, 2014
Registry last updated: May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.