NCT02138058

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

May 12, 2014

Last Update Submit

May 8, 2017

Conditions

Compulsive Shopping

Keywords

compulsive buying, compulsive shopping, topiramate

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Compulsive-Obsessive Scale Shopping Version

    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 Outcomes (2)

  • Clinical Global Impression scale (CGI)

    12 weeks

  • Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU)

    12 weeks

Other Outcomes (1)

  • Social adjustment

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

a 12 week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention

Behavioral: Cognitive restructuring intervention

topiramate

EXPERIMENTAL

a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention

Drug: TopiramateBehavioral: Cognitive restructuring intervention

Interventions

TopiramateDRUG
topiramate
Cognitive restructuring interventionBEHAVIORAL

4 sessions of a manualized cognitive restructuring intervention for compulsive buying

Also known as: behavioral
Placebotopiramate

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação Viver Bem

São Paulo, São Paulo, 05404-010, Brazil

Location

Related Links

MeSH Terms

Interventions

Topiramate

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Hermano Tavares, Professor

    associate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 14, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 9, 2017

Record last verified: 2015-12

Locations

BR(1)