Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Time to reorientation (TRO)
研究概览
简要总结
This study was a prospective, open-label comparative effectiveness clinical trial, comparing magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).
详细描述
Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than ECT in randomized trials of efficacy. However, there are currently no real-world effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed best for the patient. The aims of this study are to: (1) Evaluate the comparative effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment and treatment response.
Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to consent
- •Clinically indicated for seizure therapy
- •Patients with MDD who had either never received antidepressant treatment or had discontinued antidepressants by their own choice for at least six weeks prior to enrollment (as commonly done in routine clinical care in this jurisdiction due to more negative views of psychotropics)
- •18-65 years of age.
排除标准
- •History of significant head trauma
- •Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
- •Substance dependence
- •Active comorbidity with another psychiatric disorder
- •Patients who had previously received ECT or TMS
- •Current unstable or serious medical illness (e.g., myocardial infarction)
- •Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
- •Inability to participate in testing
研究组 & 干预措施
Electroconvulsive Therapy (ECT)
Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT
干预措施: Electroconvulsive Therapy (n=30) (Device)
Magnetic Seizure Therapy (MST)
High-dose magnetic seizure therapy (HD-MST)
干预措施: Magnetic Seizure Therapy (n=30) (Device)
结局指标
主要结局
Time to reorientation (TRO)
时间窗: approximately 2.5 weeks
Cognition primarily assessed by Time to Reorientation (TRO)
Depression Scale
时间窗: approximately 2.5 weeks
Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
次要结局
- Brain Single Photon Emission Computed Tomography (SPECT)(approximately 2.5 weeks)
- Wechsler Memory Scale - Revised:(approximately 2.5 weeks)
- Wisconsin Card Sorting Test(approximately 2.5 weeks)