Efficacy and Tolerability of Magnetic Seizure Therapy (MST) as an Alternative to Electroconvulsive Therapy (ECT) for Treatment Resistant Depression, Schizophrenia, and Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS)
研究概览
简要总结
Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive disorder (OCD). However, its use is limited by significant adverse effects on memory and cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is currently under investigation as a targetable, cognition-sparing alternative to ECT. MST uses magnetic fields rather than electrical stimuli for seizure induction, dramatically reducing the passage of induced current through undesired brain regions. 10 years of experimental studies have established the safety of MST in animal and human subjects. This pilot study will investigate whether MST has similar efficacy to ECT, with fewer cognitive side effects, in patients with severe depression, schizophrenia, and OCD.
详细描述
Although ECT is effective against severe depression, psychosis, and OCD, it also produces significant impairments of autobiographical memory and other cognitive functions. These side effects limit the acceptability and tolerability of ECT in many patient populations. They also limit the number of treatments that can be administered in a course of ECT, leading to high relapse rates once ECT is discontinued. In animal studies, MST has been shown to have far fewer adverse cognitive effects than ECT. In small human studies, humans have shown faster subjective and objective recovery of orientation after MST than with ECT. However, the precise degree of cognitive sparing in MST versus ECT has yet to be established. Likewise, the comparative efficacy of MST versus ECT in severe depression, schizophrenia, and OCD remains to be seen. The investigators aim to determine whether MST spares autobiographical memory and other cognitive functions, while retaining comparable efficacy to that of ECT.
Objective 1: To compare the efficacy of MST and ECT in treating patients with severe depression, schizophrenia, and OCD.
Hypothesis 1: MST will have equivalent efficacy to ECT on objective measures of mood, schizophrenia, and OCD symptoms.
Objective 2: To compare the effects of MST and ECT on autobiographical memory and other cognitive functions in patients with severe depression, schizophrenia, schizoaffective disorder and OCD.
Hypothesis 2: MST will have significantly lower adverse effects on objective measures of autobiographical memory and other cognitive functions in patients with severe depression, schizophrenia, and OCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 to 85
- •DSM-IV diagnosis of major depressive episode with or without psychotic features in the context of MDD or bipolar disorder; OCD or Schizophrenia
- •24-item HRSD score of ≥ 21 (for depression subjects)
- •18-item BPRS score of ≥ 37 (for schizophrenia subjects)
- •Y-BOCS score of ≥ 16 (for OCD subjects)
- •demonstrate capacity to give informed consent
- •are a Canadian resident
排除标准
- •have an unstable medical and/or neurological condition
- •are currently pregnant or lactating
- •are not considered sufficiently well to undergo general anesthesia for any reason
- •have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
- •are taking a benzodiazepine at a dose greater than lorazepam 2mg or equivalent
- •are taking any non-benzodiazepine anticonvulsant
- •have active substance misuse or dependence within the past 3 months
- •have a current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
- •have a co-morbid borderline personality disorder and/or antisocial personality disorder
- •have had a history of any suicide attempts in the past 6 months
结局指标
主要结局
Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS)
时间窗: Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks
i) The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms. ii) The Y-BOCS is a clinician-rated scale used to assess the severity of OCD symptoms. iii) The BPRS is a clinician-administered scale used to assess the severity of various psychiatric symptoms, such as depression, anxiety, hallucinations, and delusions. In this study, it will be used with participants diagnosed with schizophrenia.
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
时间窗: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment
次要结局
- Cognitive Functioning(Change from baseline in cognitive functioning at 6 months after final treatment)
- Neuroimaging (brain structure and activity)(Changes from baseline in brain structure and activity at 6 months after final treatment)
研究者
Z. J. Daskalakis
Chair, Temerty Centre for Therapeutic Brain Intervention
Centre for Addiction and Mental Health