Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS); Randomized Controlled Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks) and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and designated clinicians will complete a battery of instruments that measure relevant symptoms (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4 time points: after the inclusion, after the first week of treatment, after the second week (the end of treatment for experimental group), after the fourth week (the end of treatment for control group), and after 1 month (follow-up for both groups). Interim data analysis is planned at the time when at least 30 participants are involved in both groups. Patients whose baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be included in another study; they will be treated with accelerated deep TMS twice a day during 4 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2)
- •current depressive episode lasts for at least 4 weeks
- •HAM-D17 score ≥15
- •CGI-Score ≥4
- •inadequate response to antidepressant therapy
排除标准
- •diagnosed psychotic disorder
- •diagnosed depressive disorder with psychotic features
- •diagnosed bipolar affective disorder
- •diagnosed posttraumatic stress disorder
- •diagnosed obsessive-compulsive disorder
- •anxiety disorder or personality disorder as primary diagnoses
- •alcohol or drug addiction
- •neurological disorders and brain implants
- •pregnancy
- •former TMS treatment within 6 months
- •unable to complete the questionnaires
结局指标
主要结局
Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores
时间窗: 8 weeks
The Hamilton Rating Scale for Depression (HAM-D) is a clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. The items are scored either on a 3-point or 5-point scale, and all the values are summed to obtain a total scale score. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression (the maximum score being 52).
次要结局
- The proportion of patients who experienced complete remission of the disease(8 weeks)
- Change in cognitive functions (MoCA test)(8 weeks)
- Treatment response(8 weeks)
- Percentage improvement in BDI-II scores(8 weeks)
- Change in perceived quality of life (EQ-5D-5L scale)(8 weeks)