A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Changes in Y-BOCS scale scores relative to baseline
研究概览
简要总结
This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.
详细描述
Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 to 60 years
- •diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).
排除标准
- •subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse
- •significant head injury, or of any neurosurgical procedure
- •pregnant women
- •patients with metal implants or illnesses that prevent attendance to sessions
- •patients with a history of seizure or bearing pacemakers
研究组 & 干预措施
Transcranial Magnetic Stimulation
Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham Transcranial Magnetic Stimulation
Sham transcranial magnetic stimulation over the supplementary motor areas.
干预措施: Sham repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Changes in Y-BOCS scale scores relative to baseline
时间窗: assessments were at baseline, at 2 weeks and at 3 months
Y-BOCS: Yale-Brown Obsessive-Compulsive Scale
次要结局
未报告次要终点
研究者
Joaquim Brasil-Neto
Dr.
University of Brasilia