Topiramate Trial for Compulsive Buying (TFO)

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Compulsive Shopping

Treatments: Drug: Topiramate; Behavioral: Cognitive restructuring intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02138058

Topiramate for oniomania

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Cognitive restructuring intervention

topiramate

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive restructuring intervention

Drug: Topiramate