Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.
详细描述
Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.
Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score<10.
Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
- •Montgomery and Asberg depression scale > 20
排除标准
- •other psychiatric features, rapid cycles
- •Benzodiazepines intake
- •pregnancy
研究组 & 干预措施
active iTBS
Participants will receive 10 to 30 sessions of active intermittent theta burst stimulation (iTBS) consisting in delivering 2 s train of bursts containing three pulses at 50 Hz repeated each 200 ms every 10 s (iTBS). Each iTBS session contained 990 pulses and lasted 6 min. Stimulation intensity will be set at 80% of the patient's resting motor threshold. iTBS will be applied twice per day, with at least three hours between each session. Ten to 30 sessions will be delivered until patient achieved remission (i.e., 13-item Beck Depression Inventory (BDI13) score < 10). iTBS will be applied over the left dorsolateral prefrontal cortex (DLPFC) according to the individual's 3D-T1 MRI.
干预措施: active iTBS (Device)
sham iTBS
The same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil.
干预措施: sham iTBS (Device)
结局指标
主要结局
Beck Depression Inventory
时间窗: 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)
Self-reported clinical scale with 13 items
次要结局
未报告次要终点