Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Difference in MADRS-S from baseline to three weeks after first iTBS treatment
研究概览
简要总结
Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression.
The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days).
Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
- •MADRS-S >= 20
- •unchanged medication last month
- •unchanged psychological treatment last month
- •admitted to psychiatric ward last month
- •no ECT or TMS last six months
- •provision of signed informed consent form
- •indication for TMS is depression
排除标准
- •addiction (illicit drugs or alcohol)
- •pregnancy
- •conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil
- •implanted device that is activated or controlled in any way by physiological signals
- •implanted mediation pumps
- •intracardiac lines, even when removed
- •regular use of benzodiazepines
- •any condition that seriously increases the risk of non-compliance or loss of follow-up
结局指标
主要结局
Difference in MADRS-S from baseline to three weeks after first iTBS treatment
时间窗: 3 weeks
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
次要结局
- Difference in QIDS-SR from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in QIDS-SR from baseline to six months after first iTBS treatment(6 months)
- Difference in EQ-VAS from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in CGI-I from baseline to three weeks after first iTBS treatment(3 weeks)
- Difference in MADRS-S from baseline to two weeks after first iTBS treatment(2 weeks)
- Difference in MADRS-S from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in QIDS-SR from baseline to two weeks after first iTBS treatment(2 weeks)
- Difference in SDS from baseline to six months after first iTBS treatment(6 months)
- Difference in CGI-S from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in CGI-I from baseline to six weeks after first iTBS treatment(6 weeks)
- Number of patients in remission three weeks after first iTBS treatment(3 weeks)
- Difference in MADRS-S from baseline to five weeks after first iTBS treatment(5 weeks)
- Difference in MADRS-S from baseline to six months after last iTBS treatment(6 months)
- Difference in QIDS-SR from baseline to one week after first iTBS treatment(1 week)
- Difference in QIDS-SR from baseline to four weeks after first iTBS treatment(4 weeks)
- Difference in QIDS-SR from baseline to five weeks after first iTBS treatment(5 weeks)
- Difference in SDS from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in EQ-VAS from baseline to three weeks after first iTBS treatment(3 weeks)
- Difference in MADRS-S from baseline to one week after first iTBS treatment(1 week)
- Difference in QIDS-SR from baseline to three weeks after first iTBS treatment(3 weeks)
- Difference in EQ-VAS from baseline to six months after first iTBS treatment(6 months)
- Difference in MADRS-S from baseline to four weeks after first iTBS treatment(4 weeks)
- Difference in CGI-S from baseline to three weeks after first iTBS treatment(3 weeks)
- Number of patients in remission six weeks after first iTBS treatment(6 weeks)