The Effects of Thetaburst Stimulation in Treatment Resistant Unipolar Depressed Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Depression severity of Theta burst treatment after 1 week of treatment.
研究概览
简要总结
50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes. Patients will be selected using the structured Mini-International Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed.
All patients will be closely matched for gender and age with 50 never-depressed medication-free healthy volunteers. Only baseline measurements will be collected: no volunteer will undergo the treatment.
We expect that real Theta burst treatment and not sham will result in a significant and clinical meaningful response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •antidepressant-free unipolar depression
- •age between 18 and 65 years
- •right handed
- •at least stage I treatment resistant
排除标准
- •current or past history of epilepsy, neurosurgical interventions, having a pacemaker or metal or magnetic objects in the brain, alcohol dependence and suicide attempts within 6 months before the start of the study.
结局指标
主要结局
Depression severity of Theta burst treatment after 1 week of treatment.
时间窗: After 1 week of TBS-rTMS/sham treatment.
Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS).
Depression severity will be assessed at the end of the final second week of the stimulation protocol.
时间窗: At the end of the final second week of the stimulation protocol.
Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS).
Depression severity will be assessed two weeks after stimulation.
时间窗: Two weeks after stimulation.
Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS).
Suicidal ideation will be assessed at baseline.
时间窗: At baseline.
Suicidal ideation will be assessed with the suicidal ideation scale (SSI).
Depression severity in Theta burst treatment at baseline.
时间窗: At baseline.
Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS).
Suicidal ideation will be assessed after 1 week of treatment.
时间窗: After 1 week of TBS-rTMS/sham treatment.
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).
Suicidal ideation will be assessed at the end of the final second week of the stimulation protocol.
时间窗: At the end of the final second week of the stimulation protocol.
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).
Suicidal ideation will be assessed two weeks after stimulation.
时间窗: Two weeks after stimulation.
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).
次要结局
- Resting state functional connectivity; diffusion MRI at baseline.(At baseline.)
- Resting state functional connectivity; diffusion MRI after 1 week of treatment.(After 1 week of TBS-rTMS/sham treatment.)
- Resting state functional connectivity; diffusion MRI at the end of the final second week of the stimulation protocol.(At the end of the final second week of the stimulation protocol.)