Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in Positive and Negative Symptom Scale (PANSS)
研究概览
简要总结
This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.
详细描述
Psychosis is recognized as one of the largest contributors to nonfatal health loss, and substantial portion of patients exhibit resistance to antipsychotics, emphasizing the need for exploring non-pharmacological treatments. In clinical practice, Electroconvulsive therapy (ECT) has been shown to be generally effective in psychosis, but its clinical use sometimes is limited by its cognitive side effects. Magnetic Seizure Therapy (MST) is a novel modification of electroconvulsive therapy (ECT). MST offers the advantages of milder side effects on cognition, a quicker return of orientation, and a shorter duration of post-ictal confusion. A few studies have studied the antipsychotic effect of MST. Therefore, the present study will plan to perform a clinical trial to compare the efficacy of MST treatment plus antipsychotics to antipsychotic medications alone among psychotic disorders in acute phase. In addition, whether MST treatment plus antipsychotics will bring a quicker efficacy response than antipsychotic medications alone is also of important clinical significance. The present trial will plan to administer 10 sessions of MST in 2 weeks, in which the patients will be randomly allocated to either receiving MST+medications or receiving medications alone. After the 2 week's research intervention, all patients will be switched to clinical routine management, but kept under masked clinical assessment for 4 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) meets the diagnostic criteria for schizophrenia or other primary psychotic disorders according to DSM-5;
- •(2) age range between 18 and 55 years;
- •(3) Positive And Negative Syndrome Scale (PANSS) score≥60;
- •(4) to provide informed consent.
排除标准
- •(1) have a concomitant severe medical illness;
- •(2) are pregnant or intend to get pregnant during the study;
- •(3) have a history of DSM-5 diagnosis of substance dependence or abuse within the past three months;
- •(4) history of traumatic brain injury (with a screening scale score of 7 or above);
- •(5) history of poor response to electroconvulsive therapy or MST;
- •(6) have probable dementia based on study investigator assessment; have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
- •(7) presenting with a medical condition, medication, or laboratory anomaly deemed by the investigator to potentially induce psychotic symptoms, or significant cognitive impairment. (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
- •(8) have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- •(9) a score of 18 or more on the 24-item Hamilton Depression Rating Scale (HAM-D);
- •(10) needing ECT treatment immediately due to such dangerous symptoms as suicide, stupor or psychomotor agitation, etc.
研究组 & 干预措施
Magnetic seizure therapy plus antipsychotics
The patients will receive antipsychotic drugs plus MST during the first 2 weeks.
A TwinCoil of MagPro XP will be positioned centrally over the frontal cortex in the midline position. The output power of MagPro XP is set to 100%, and stimulation frequency is 100 Hz. For MST titration, the first step is given at a 5-second train duration; if there is no seizure, the duration is increased to 10 seconds with a maximum limit of 10 seconds. The subsequent MST treatment will be maintained at 10 seconds. This procedure will be carried out under anesthesia.
A total of up to 10 treatments will be administered to participants, usually five times a week, for 2 weeks.
干预措施: Magnetic seizure therapy by Magnetic stimulator (Device)
antipsychotic drugs
The patients will receive second-generation antipsychotic drugs without MST or ECT during the first 2 weeks.
干预措施: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc) (Drug)
结局指标
主要结局
Changes in Positive and Negative Symptom Scale (PANSS)
时间窗: Baseline, 1 weeks, 2 weeks, 6 weeks
measured by Positive and Negative Symptom Scale (PANSS)
次要结局
- Changes in cognition(Baseline, 1 weeks, 2 weeks)
- Changes of ictal EEG feature(during each treatment)
- Changes of cortical inhibition(baseline, 2 weeks)
- Changes of brain grey matter(baseline, 2 weeks)
- Changes in 24-item Hamilton Depression Rating Scale (HAM-D)(Baseline, 1 weeks, 2 weeks, 6 weeks)
- Changes in Hamilton Anxiety Scale (HAMA)(Baseline, 1 weeks, 2 weeks, 6 weeks)
- Changes in Clinical Global Impression (CGI) scale(Baseline, 2 weeks, 6 weeks)
- Changes in Global Assessment of Functioning (GAF) scale(Baseline, 2 weeks, 6 weeks)
- Changes in brain gamma band signal(Baseline, 2 weeks)
研究者
Jijun Wang
Professor of Department of Psychiatry
Shanghai Jiao Tong University School of Medicine