Double Blind Controlled Trial of Topiramate for Compulsive Buying
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Yale-Brown Compulsive-Obsessive Scale Shopping Version
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
a 12 week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention
干预措施: Cognitive restructuring intervention (Behavioral)
topiramate
a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention
干预措施: Topiramate (Drug)
topiramate
a 12 week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention
干预措施: Cognitive restructuring intervention (Behavioral)
结局指标
主要结局
Yale-Brown Compulsive-Obsessive Scale Shopping Version
时间窗: 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
次要结局
- Udvalg for KliniskeUndersøgelser Side Effect Rating Scale (UKU)(12 weeks)
- Clinical Global Impression scale (CGI)(12 weeks)
研究者
Hermano Tavares
Associate professor
University of Sao Paulo