A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
研究概览
简要总结
The study will involve a 3-week (15 session) randomized double-blind clinical trial of two repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment resistant depression. rTMS site selection will be localized from structural MRI scans.
The patients will be randomized to one of two conditions
- rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
- rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral prefrontal cortex targeted control).
详细描述
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of less than or equal to 10.
Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also administered.
Inclusion Criteria:
- Moderate to severe depressive symptoms as indicated as MADRS >20
- Failure to respond to a minimum of two antidepressant medications
- No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial Exclusion Criteria
- Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
- In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Educational Counseling Training
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe depressive symptoms as indicated as MADRS >20
- •Failure to respond to a minimum of two antidepressant medications
- •No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial
排除标准
- •Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- •Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
- •In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
- •Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder
结局指标
主要结局
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
次要结局
- Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale).