Topiramate Trial for Compulsive Buying (TFO)

May 8, 2017 updated by: Hermano Tavares, University of Sao Paulo

Double Blind Controlled Trial of Topiramate for Compulsive Buying

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05404-010
        • Associação Viver Bem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
a 12 week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention
Behavioral: Cognitive restructuring intervention
4 sessions of a manualized cognitive restructuring intervention for compulsive buying
Other Names:
  • behavioral
EXPERIMENTAL: topiramate
a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention
Drug: Topiramate
Behavioral: Cognitive restructuring intervention
4 sessions of a manualized cognitive restructuring intervention for compulsive buying
Other Names:
  • behavioral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Hermano Tavares, Professor, Associate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (ESTIMATE)

May 14, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Topiramate for oniomania

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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