Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in 17-item Hamilton Depression Rating Scale
研究概览
简要总结
The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of major depressive disorder according to DSM-5
- •Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than
- •Before treatment, patient have to stop antidepressant for at least 1 weeks.
- •Capable and willing to provide informed consent.
排除标准
- •Have a concomitant major, unstable medical or neurologic illness :
- •Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
- •Severe brian disease: Brain tumor, encephalitis, brian injury.
- •Intracranial implant and other ferromagnetic materials close to the head.
- •History of Seizures.
- •Cardiac pacemaker.
结局指标
主要结局
Change in 17-item Hamilton Depression Rating Scale
时间窗: Baseline, Week 1, Week 2, Week 4
17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)
Change in Beck Anxiety Inventory
时间窗: Baseline, Week 1, Week 2, Week 4
Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)
Change in Montgomery-Asberg Depression Rating Scale
时间窗: Baseline, Week 1, Week 2, Week 4
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
次要结局
- Response rate after 2-week treatment at the end of iTBS (MADRS)(Baseline, Week 1, Week 2, Week 4)
- Changes in Clinical Global Index Severity(Baseline, Week 1, Week 2, Week 4)
- Changes in EEG band(Baseline, Week 1, Day 3, Week 2, Week 4)
- Change in TSH(Baseline, Week 2)
- Change in T3(Baseline, Week 2)
- Change in cortisol(Baseline, Week 2)
- Change in BDNF(Baseline, Week 2)
- Change in T4(Baseline, Week 2)
- Response rate after 2-week treatment at the end of iTBS (HDRD-17 )(Baseline, Week 1, Week 2, Week 4)
- Changes in Heart Rate Variability (HRV) band(Baseline, Week 1, Day 3, Week 2, Week 4)
研究者
Chih-Wei Hsu
Psychiatry Department
Chang Gung Memorial Hospital