Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- the response rate
研究概览
简要总结
Despite advancements in Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) for Major Depressive Disorder (MDD), there remains a need for further research to replicate clinical outcomes and understand the therapeutic targets of these treatments. This study aims to address these gaps through a double-blinded, randomized, non-inferiority investigation comparing the efficacy, tolerability, cognitive adverse effects, and neurophysiological biomarkers of MST and bilateral ECT in patients with MDD.
详细描述
Participants will be randomly allocated to either the ECT or MST group. Each center aims to recruit 30 participants for each group, using block randomization, resulting in a total of 30 participants per group. The trial comprises a 12-session intervention phase of ECT/MST, spanning approximately 4 weeks, followed by a 12-week observation period. For the first three treatment sessions, participants will receive consecutive sessions. Subsequently, there will be a one-day interval between sessions 4 to 6, a two-day interval between sessions 7 to 9, and a three-day interval between sessions 10 to 12, ensuring completion within a month. Following treatment completion, participants will undergo follow-up clinical observations every four weeks for 12 weeks. EEG and ECG recordings will be obtained at baseline, post-session 3, 6, 9, 12 (3 hours after each session), and at the 12-week follow-up. All evaluations will be conducted under standardized conditions throughout the sessions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Both clinical staff and participants were blinded to the treatment assignment.
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
- 否
入选标准
- •Participants must meet the diagnostic criteria for MDD as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •Participants must have a baseline score of 18 or higher on the 24-item Hamilton Depression Rating Scale (HDRS-24).
- •During the trial's treatment period, participants must be using a single antidepressant medication at a stable dose.
- •Participants must be between the ages of 18 and 65 years.
- •Informed consent from both parents and legal guardians is required.
排除标准
- •Individuals with current or history of organic brain disorders or neurological disorders will be excluded from the study.
- •Participants with a Wechsler Abbreviated Scale of Intelligence (WASI) score of less than 70 will be excluded.
- •Individuals currently taking antiepileptic drugs, benzodiazepines, or other medications that may affect seizure activity will be excluded from the study.
- •Those with exposure to ECT, modified ECT, MST, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments in last 6 months will be excluded.
- •Individuals with cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain will be excluded from participation.
- •Pregnant or lactating individuals will be excluded from the study.
- •Individuals currently participating in another concurrent clinical trial will not be eligible for inclusion.
- •Participants who refuse to provide informed consent to participate in the trial will be excluded.
- •Other circumstances deemed unsuitable for participation by researchers will result in exclusion.
结局指标
主要结局
the response rate
时间窗: 12 weeks
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the response rate is defined as a reduction of at least 50% in the HDRS-24 score from baseline.
the remission rate
时间窗: 12 weeks
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the remission rate is defined as a reduction of at least 60% in the HDRS-24 score and a total score of 8 or less.
次要结局
未报告次要终点
研究者
Tianhong ZHANG
Associate Professor
Shanghai Mental Health Center