Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)
研究概览
简要总结
Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.
This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •major Depression
- •informed consent
排除标准
- •seizures in medical history
- •metallic implants
- •deep brain stimulation
- •cardiac pacemaker
- •brain trauma
- •psychotic symptoms
- •substance abuse
- •pregnancy
- •Benzodiazepines other than Lorazepam >1mg/d
研究组 & 干预措施
bilateral theta burst stimulation to the DLPFC
intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC
干预措施: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) (Device)
Sham stimulation
Sham stimulation with a 45° tilted coil
干预措施: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) (Device)
结局指标
主要结局
Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)
时间窗: after the end of treatment (week 6)
次要结局
- Change of the Hamilton rating scale for depression (HAMD 17)(baseline, after the end of treatment (week 6))
- Change of the Beck Depression Inventory (BDI)(baseline, after the end of treatment (week 6))
- Change of the Montgomery-Asberg rating scale for depression (MADRS) score(baseline, after the end of treatment (week 6))
研究者
Christian Plewnia, MD
Prof. Dr. med.
University Hospital Tuebingen