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Topiramate Trial for Compulsive Buying (TFO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138058
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hermano Tavares, University of Sao Paulo

Study Description
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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

Condition or disease Intervention/treatment Phase
Compulsive Shopping Drug: Topiramate Behavioral: Cognitive restructuring intervention Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Controlled Trial of Topiramate for Compulsive Buying
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arms and Interventions
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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 Name: 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 Name: behavioral


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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 Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138058


Locations
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Brazil
Associação Viver Bem
São Paulo, SP, Brazil, 05404-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Hermano Tavares, Professor associate
More Information
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Additional Information:

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Responsible Party: Hermano Tavares, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02138058    
Other Study ID Numbers: Topiramate for oniomania
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: December 2015
Keywords provided by Hermano Tavares, University of Sao Paulo:
compulsive buying, compulsive shopping, topiramate
Additional relevant MeSH terms:
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Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs