A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Impulsive state
研究概览
简要总结
The purpose of this pilot study is to evaluate the effects of Atomoxetine, a selective noradrenaline reuptake inhibitor, on impulsivity in patients with Tourette's syndrome.
详细描述
High impulsivity characterizes severe forms of Tourette's syndrome, in which motor and vocal tics are associated with various neuropsychiatric disorders as compulsive disorders, difficult to manage and impairing quality of life of patients and their family. Previous preclinical study and clinical studies in attention-deficit hyperactivity disorder and Parkinson's disease demonstrate that atomoxetine, a selective noradrenaline reuptake inhibitor, improves response inhibition in high impulsive individuals. However, there is no suffisant data in Tourette's syndrome. The purpose of this pilot study is to evaluate the effects of Atomoxetine on impulsivity in 10 to 35 years old patients with Tourette's syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High impulsive patients, aged 10-35 years old, diagnosed for Tourette's syndrome as defined by the DSM-IV, never treated by Atomoxetine
- •The use of effective contraception or abstinence for subjects of reproductive age
- •Written informed consent
排除标准
- •Patients with mental retardation, psychotic disorders as schizophrenia, autism spectrum disorders, chronic tics which do not respond to Tourette's syndrome criteria.
- •Actual severe depression
- •Allergy to one of the constituents
- •Severe cardiovascular or cerebrovascular diseases, Pheochromocytoma, uncontrolled hyperthyroidism, closed angle glaucoma
- •IMAO treatment discontinued less than 2 months or contra-indicated associated treatment
研究组 & 干预措施
patients with Tourette's syndrome
Atomoxetine in Patients With Tourette's Syndrome
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Impulsive state
时间窗: 8 weeks
The primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB)
次要结局
- Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance(8 weeks)