Magnetic Seizure Therapy for Schizophrenia - Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Brief Psychiatric Rating Scale (BPRS) Response (18-Version)
研究概览
简要总结
This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).
详细描述
The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in two academic institutions (the Centre for Addiction and Mental Health (CAMH) in Toronto, and University of British Columbia (UBC) Hospital in Vancouver, British Columbia). The investigators will compare MST to right unilateral ultrabrief pulse ECT (RUL-UB-ECT). Treatment will be administered two to three days per week. Clinical response will be assessed with the 18-item Brief Psychiatric Rating Scale (BPRS). Response will be defined as greater than or equal to 40% decrease in the BPRS positive psychotic symptom subscale (4 items - hallucinatory, behavior, suspiciousness, conceptual disorganization, and unusual thought content). Patients who do not meet response criteria after 15 treatment sessions will be considered non-responders and will cease treatment sessions. The blind will not be broken to participants until the completion of the entire study.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be fixed and study personnel will be blinded to the randomization block size.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are inpatients or outpatients;
- •demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);
- •have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);
- •are 18 years of age or older;
- •have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;
- •have a BPRS score at baseline of at least moderate severity (>4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;
- •are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;
- •are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;
- •are able to adhere to the intervention schedule;
- •meet the MST safety criteria;
- •If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.
排除标准
- •have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;
- •have a concomitant major unstable medical illness;
- •are pregnant or intend to get pregnant during the study;
- •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;
- •present with a serious medical condition,
- •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;
- •require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
- •are unable to communicate in English fluently enough to complete the neuropsychological tests;
- •have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
研究组 & 干预措施
Magnetic Seizure Therapy (MST)
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
干预措施: Magnetic Seizure Therapy (MST) (Device)
Electroconvulsive Therapy (ECT)
ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma.
干预措施: Electroconvulsive Therapy (ECT) (Device)
结局指标
主要结局
Brief Psychiatric Rating Scale (BPRS) Response (18-Version)
时间窗: Greater than 8 treatments (2.5 weeks)
The scale is used to quantify psychiatric symptoms such as anxiety, depression, hallucinations, and unusual behaviours. The scale range is 18-126. A lower score indicates lower severity in anxiety, depression, and positive psychotic symptoms. A higher score indicates higher severity in negative and positive psychotic symptoms.
MATRICS™ Consensus Cognitive Battery (MCCB)
时间窗: Greater than 8 treatments (2.5 weeks)
The MCCB Assessments: The battery of cognitive assessments (ten in total) is intended to provide evaluation of key cognitive domains relevant to schizophrenia and related disorders and be a measure of cognitive change before and after the treatment course. The ten tasks focus on the following cognitive domains: speed of processing; attention/vigilance; working memory; verbal learning; visual learning; reasoning and problem solving; and social cognition.
次要结局
- Scale for Suicidal Ideation (SSI)(Greater than 8 treatments (2.5 weeks))
- The Calgary Depression Scale for Schizophrenia (CDSS)(Greater than 8 treatments (2.5 weeks))
- Autobiographical Memory Test (AMT)(Greater than 8 treatments (2.5 weeks))
- Montreal Cognitive Assessment (MoCA)(Greater than 8 treatments (2.5 weeks))