Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- reduction in the MADRS-S score
研究概览
简要总结
Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.
Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.
Primary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.
Secondary objectives: Include testing for differences in:
- Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI).
- Response to treatment (a decrease of 50% on MADRS-S)
- Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS).
- Drop-out from treatment.
- Stimulation site pain measured with the Numerical Rating Scales (NRS).
- Adverse events.
- Admission and suicides within 6 months.
- New treatment course of rTMS or ECT within 6 months
- Remission (score < 11 on the MADRS-S)
- Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS).
Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients.
Inclusion criteria:
- At least 18 years of age at the time of inclusion.
- A clinical diagnosis of unipolar or bipolar depression according to ICD-10.
- Acceptance of rTMS.
- A Swedish personal identity number.
- Capable of giving informed consent.
Exclusion criteria:
• If the investigator judges one of the two treatment protocols inappropriate for the patient.
Inclusion time: 2025-07-01 to 2029-01-01
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
- •At least 18 years of age at the time of inclusion.
- •A clinical diagnosis of unipolar or bipolar depression according to ICD-
- •Acceptance of rTMS.
- •A Swedish personal identity number.
- •Capable of giving informed consent.
排除标准
- •If the investigator judges one of the two treatment protocols inappropriate for the patient.
研究组 & 干预措施
right-sided rTMS
right-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation
干预措施: repetitive transcranial magnetic stimulation (Device)
left-sided iTBS
left-sided intermittent theta burst stimulation
干预措施: intermittent theta burst stimulation (Device)
结局指标
主要结局
reduction in the MADRS-S score
时间窗: 6 weeks
reduction in the MADRS-S score from baseline to the end of treatment
次要结局
- Stimulation site pain(15 minutes)
- CGI-I(6 weeks)
- Patient rate remission(6 weeks)
- Patient rated response(6 weeks)
- Self-rated EQ-5D-VAS(6 weeks)
- Drop-out(6 weeks)
- Adverse events(6 weeks, follow-up at 6 months)
- Self-rated EQ-5D-VAS at 6-month follow-up(6 months)
- Self rated remission at 6-month follow-up(6 months)
- Hospital admission(6 months)