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Topiramate Trial for Compulsive Buying

Double Blind Controlled Trial of Topiramate for Compulsive Buying

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02138058
Acronym
TFO
Enrollment
42
Registered
2014-05-14
Start date
2015-01-31
Completion date
2016-06-30
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compulsive Shopping

Keywords

compulsive buying, compulsive shopping, topiramate

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.

Interventions

DRUGTopiramate
BEHAVIORALCognitive restructuring intervention

4 sessions of a manualized cognitive restructuring intervention for compulsive buying

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Yale-Brown Compulsive-Obsessive Scale Shopping Version12 weeksIt 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

MeasureTime frameDescription
Clinical Global Impression scale (CGI)12 weeksThe 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)12 weeksIt 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

MeasureTime frameDescription
Social adjustment12 weeksThe 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026