Efficacy of Adjunctive Theta Burst Transcranial Magnetic Stimulation in Bipolar Depression -A Randomized Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess and compare the change in Depressive symptoms in Bipolar Depression among active and placebo group
研究概览
简要总结
This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC in bipolar depression. For this study Bipolar depressed patients will be selected by a certified psychiatrist. The presence of exclusion criteria will be evaluated. Eligible patients will undergo Baseline clinical assessments and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 15 (3 sessions per day)continuous Theta Burst Stimulation (cTBS) session (200 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 5 days a week. A stimulation intensity of 80% of the subject’s motor threshold (MT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. Two post-treatment assessment will take place respectively 7 days and 21 days post initiation of treatment .
1. (1) Chung S, Hoy K , Fitzgerald P. Theta-burst stimulation: a new form of TMS treatment for depression. Depression and Anxiety *.*2014;32(3): 182-192.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of moderate to severe Bipolar disorder with current episode of Depression 2) Baseline HAM-D Score >18 3) Right Handed nor Mo tensive patient.
排除标准
- •Neurological Disorder such as epilepsy,organic brain damage or any neurological procedure.
- •Pacemakers or other metal parts in the body 3) ECT in the past 6 months 4) Any comorbid Psychosis 5) History of non response to rTMS treatment 6) Alcohol or any other substance dependence except Nicotine and Caffine.
结局指标
主要结局
To assess and compare the change in Depressive symptoms in Bipolar Depression among active and placebo group
时间窗: Screening ,Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy
次要结局
- To assess and compare change in anxiety symptoms in bipolar depression(Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy)
- To assess and compare change in quality of life in bipolar depression(Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy)
- To assess and compare change in sexual dysfunction in bipolar depression(Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy)