Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale Total Score.
研究概览
简要总结
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12-80 years;
- •Diagnosis confirmed by two psychiatrists per DSM-5;
- •Stable medication regimen pre-enrollment;
- •Indicated for neuromodulation OR with visual field defects.
排除标准
- •Major systemic diseases;
- •Prior neuromodulation within 3 months;
- •Pregnancy or potential pregnancy;
- •Metal implants or claustrophobia.
研究组 & 干预措施
Magnetic Seizure Therapy (MST) Group
Participants with Major Depressive Disorder (MDD) receive active Magnetic Seizure Therapy (MST) according to the study protocol, in addition to their ongoing standardized pharmacotherapy. This group assesses the efficacy and cognitive effects of MST, allowing for comparison with ECT.
干预措施: Magnetic Seizure Therapy (Device)
Electroconvulsive Therapy (ECT) Group
Participants with Major Depressive Disorder(MDD) receive active Electroconvulsive Therapy (ECT) according to the study protocol, in addition to their ongoing standardized pharmacotherapy. This group assesses the efficacy and cognitive effects of ECT.
干预措施: Electroconvulsive Therapy (Device)
结局指标
主要结局
Change in Hamilton Depression Rating Scale Total Score.
时间窗: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
The Hamilton Depression Rating Scale is a clinician-administered scale used to assess the severity of depressive symptoms. The 17-item version (HAMD-17) is most common. Each item is rated on a 3- or 5-point scale. The total score ranges from 0 to 52, with a higher score indicating more severe depression. The primary endpoint is the change in total score from baseline.
Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG).
时间窗: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
ECG recordings will be analyzed to assess changes in heart rate variability (HRV) as a potential biomarker of autonomic nervous system function in response to treatment. Key parameters include the root mean square of successive differences (RMSSD) and the standard deviation of NN intervals (SDNN).
Change in Hamilton Anxiety Rating Scale Total Score.
时间窗: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
The HAMA is a 14-item clinician-rated scale assessing anxiety severity. Total score ranges from 0 to 56, with higher scores indicating worse anxiety. The change from baseline to the end of treatment will be the primary measure of clinical efficacy.
Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery.
时间窗: Baseline and after the completion of the last session (an average of 2 weeks).
The MCCB is a standardized, performance-based cognitive battery used to assess global cognitive functioning. The primary measure is the change in the Overall Composite T-score (derived from 10 tests across 7 domains), with higher scores indicating better cognitive performance. Assessments are administered by trained personnel.
次要结局
- Change in resting-state brain activity in specific brain regions.(Baseline and after the completion of the last session (an average of 2 weeks).)
研究者
Yanghua Tian
Vice President of Anhui Medical University
The Second Hospital of Anhui Medical University