The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 7
- 主要终点
- Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
研究概览
简要总结
Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Of these, retrograde memory loss is most concerning, and can be long-term. The introduction of ultrabrief right unilateral (UBRUL) ECT into clinical practice has been an important step in reducing the risk of memory impairment, but significant deficits still occur.
A new form of UBRUL ECT which utilises a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal UBRUL has good efficacy and less cognitive side effects than UBRUL given using the conventional Temporoparietal electrode placement. Designed as a pivotal trial, this protocol will be the first RCT comparing these two forms of ECT, producing the rigorous efficacy and safety data required to change clinical practice/policy.
This is a multicentre, parallel group RCT with 1:1 allocation ratio between Frontoparietal (intervention) and Temporoparietal (comparator) forms of UBRUL ECT. Participation will involve receiving randomised acute ECT under blinded conditions during the randomised acute treatment period (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomised acute ECT treatments, though the number of treatments (and hence the length of the randomised acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgement.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors completing assessments of mood (primary outcome) will be blinded to the participant's treatment allocation until the database is locked and the primary analysis completed. Hospital ward personnel, if not involved in the delivery of ECT, will also be blinded.
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
- •DSM-5 diagnosis* of major depressive episode (unipolar or bipolar)
- •HRSD-17 score ≥ 17 at Screening
- •At least 18 years old
- •Able to tolerate washout of prohibited medications and restriction on benzodiazepine dosage, as determined by patient's own treating psychiatrist.
- •ECT indicated for treatment of depression, as determined by own treating referring psychiatrist and confirmed by research evaluations (e.g., diagnosis of depression)
- •Willing and able to participate in research and comply with study requirements
- •Sufficient proficiency in spoken English to ensure validity of neuropsychological testing (e.g., worked or studied in an English-speaking context or equivalent)
排除标准
- •History of schizophrenia, schizoaffective disorder, other [non-mood disorder] psychosis, or rapid cycling bipolar disorder (DSM-5 diagnoses*)
- •Current manic episode, hypomanic episode, or major depressive episode with mixed features (DSM-5 diagnoses*)
- •Alcohol or substance use disorder (other than caffeine or nicotine) present in the past month, or is likely to be present during the 24-week study period as determined by study physician evaluation
- •Diagnosis of amnestic disorder, dementia, delirium, or epilepsy, as determined by study physician evaluation and medical history
- •Central nervous system disease or brain injury that has resulted in significant cognitive impact, as determined by study physician evaluation and medical history
- •Serious or unstable medical condition, as determined by study physician evaluation and medical history
- •If female of childbearing potential: a) pregnancy as determined by pregnancy urine screen
- •Completed an acute course of ECT during the past 2 months, as determined by treatment history
- •Received any ECT during the past 2 weeks
- •Failed an adequate course of ECT (i.e., 8 ECT treatments ) in the current depressive episode
- •Patients who are prisoners, and those who lack capacity to make medical decisions (as judged by their own treating psychiatrist)
- •Currently enrolled in another interventional clinical trial
- •Currently using another investigational device or product
- •DSM-5 psychiatric diagnoses will be assessed and confirmed using the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) Version 7.0.2 for DSM-5, administered by research team members.
研究组 & 干预措施
Frontoparietal ECT Group
Participants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes.
干预措施: Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy (Procedure)
Temporoparietal ECT Group
Participants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes.
干预措施: Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy (Procedure)
结局指标
主要结局
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
时间窗: From baseline to end of randomized acute treatment (typically 4 weeks)
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
次要结局
- Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17(From end of acute ECT treatment up to 24-week follow-up)
- Clinical Global Impression-Improvement (CGI-I)(Through the randomized acute ECT treatment period (typically 4 weeks))
- Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores(From Baseline to end of randomized acute treatment (typically 4 weeks))
- Clinical Global Impression-Severity (CGI-S)(From baseline to end of randomized acute treatment (typically 4 weeks))
- Number of responders(From baseline to End of Randomized Acute Treatment (typically 4 weeks))
- Number of remitters(From baseline to end of randomized acute treatment (typically 4 weeks))
- Number of participants switched from randomized treatment to another form of acute ECT(After at least 8 randomized ECT treatments (typically after 3 weeks).)
- Number of randomized ECT treatments given over the Acute Study Treatment Phase (RCT)(From baseline to End of Randomized Acute Treatment (typically 4 weeks))
- Suicidality score(From baseline to end of randomized acute treatment (typically 4 weeks))
- Post ECT reorientation time(After ECT sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.)
- Change in mean neuropsychological function(From baseline to end of randomized acute treatment (typically 4 weeks))
- Mental Health Questionnaire-14 (MHQ-14)(From baseline to end of randomized acute treatment (typically 4 weeks))
- Occurrence of adverse events and serious adverse events(From baseline and up to 24-week follow-up)