Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
详细描述
Magnetic seizure therapy (MST) is a novel, experimental therapeutic intervention, which combines therapeutic aspects of electroconvulsive therapy (ECT) and transcranial magnetic stimulation, in order to achieve the efficacy of the former with the safety of the latter. While ECT remains the most efficacious treatment available for severe and treatment-resistant depression, it is hampered by its side effect profile, specially cognitive deficits, which albeit transitory might be particularly distressing for patient, not to mention the stigma that still clings to this method. MST employs high frequency magnetic pulses applied to the head to the patient in order to induce generalized epileptic activity, thus emulating the core feature of ECT. Though distributed over a large area, such pulses do not penetrate deeper areas of the brain, therefore sparing deeper areas such as the hippocampi, which are crucial for memory encoding.
The goal of this study is to compare the antidepressant action of MST to ECT, using a non-inferiority approach. It also aims to compare the cognitive side effects profile of both interventions, as well as investigate possible neuroimaging changes and response predictors before and after treatments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be anaesthetised before the procedure, therefore will not be able to tell whether they received ECT ou MST. The preparation procedures before seizure will be identical for all participants regardless of the intervention. All monitoring and other procedures will be exactly the same for both groups. Investigator and rater will not have access to which procedure subjects received. To blind the staff, the MST sound will performed during all study interventions.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria
- •Score equal to or great than 17 points on the Hamilton Depression Rating Scale
- •Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks
- •Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist
排除标准
- •Pregnancy
- •Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency
- •Depressive symptoms due to a clinical condition
- •Any clinical or neurological conditions without proper management
- •ECT or any other neuromodulation treatment on the last six months
- •Inability to consent
研究组 & 干预措施
MST
Subjects will receive 12-18 sessions of frontal Magnetic Seizure Therapy under general anaesthesia, twice a week. Clinical and cognitive measures will be assessed before, during and after the treatment
干预措施: Magnetic Seizure Therapy (Device)
ECT
Subjects will receive 12-18 sessions of bilateral Electroconvulsive Therapy under general anaesthesia, twice a week. Clinical and cognitive measures will be assessed before, during and after the treatment
干预措施: Electroconvulsive Therapy (Device)
结局指标
主要结局
Depressive symptoms
时间窗: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Score on the 17 items Hamilton Depression Rating Scale (HDRS-17). It measures the severity of clinical symptoms, ranging from 0 to 52, with higher scores indicating greater severity.
Biographical memory
时间窗: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Score on the Autobiographical Memory Inventory (AMI). Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.
次要结局
- Depressive Symptoms(Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.)
- Suicidal Thoughts(Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.)
研究者
Andre R Brunoni
Associate Professor
University of Sao Paulo