Esketamine Versus Electroconvulsive Therapy for Suicidal Ideation in Depressive Episodes: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 6
- 主要终点
- Remission rate of suicidal ideation
研究概览
简要总结
This study is a multicenter, randomized, non-inferiority, parallel-group clinical trial designed to evaluate the efficacy and safety of esketamine compared with electroconvulsive therapy (ECT) in the treatment of suicidal ideation during depressive episodes in patients with mood disorders. Furthermore, it aims to investigate the potential mechanisms underlying the anti-suicidal effects of esketamine.
详细描述
Suicide is a major global public health concern, yet current treatments for suicidal ideation (SI) remain limited in efficacy. This study evaluates whether a two-week course of six administrations of adjunctive intravenous esketamine is non-inferior to electroconvulsive therapy (ECT) in reducing SI among adults experiencing depressive episodes of mood disorders. This multicenter, randomized, non-inferiority, parallel-group trial will enroll 340 adults diagnosed with mood disorders with clinically significant SI during a depressive episode. Participants will be randomized in a 1:1 ratio to receive either six administrations of adjunctive intravenous esketamine or ECT over a two-week intervention period, followed by a 10-week observational follow-up phase (the total study duration will be 12 weeks). The primary outcome is the rate of remission of SI, defined as a Scale for Suicidal Ideation (SSI) score of less than 4, at the end of the two-week intervention. Secondary outcomes include comparative evaluations of treatment efficacy on depressive symptoms, cognitive function, quality of life, and social functioning, as well as safety. Exploratory outcomes include the identification of biomarker and neurobiological mechanisms of treatment response through analyses of biological specimens (blood, urine, and feces), multimodal magnetic resonance imaging (MRI), and electroencephalographic (EEG) measures.
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)
盲法说明
It is not feasible to blind participants and caregivers due to the distinct nature of the interventions. Outcome assessors (independent evaluators responsible for primary and secondary outcomes, such as SI and depression severity scores) and data analysts (personnel conducting statistical analyses) will remain blinded to group assignments through the use of randomized, coded data.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous esketamine
The experimental group will receive six administrations of adjunctive intravenous esketamine over a two-week intervention period, followed by a 10-week observational follow-up phase.
干预措施: Esketamine (Drug)
Electroconvulsive therapy
The control group will receive six administrations of adjunctive ECT over a two-week intervention period, followed by a 10-week observational follow-up phase.
干预措施: Electroconvulsive therapy (Device)
结局指标
主要结局
Remission rate of suicidal ideation
时间窗: Baseline, after the sixth treatments (week 2)
The Scale for Suicide Ideation (SSI) is a 19-item clinician-administered scale assessing the severity of suicidal ideation. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 38, with higher scores indicating greater suicidal intent. The primary outcome is the rate of remission of suicidal ideation following the 2-week intervention (after 6 treatments), with the remission of suicidal ideation defined as having an SSI score of less than 4 (which indicates the absence of clinically significant suicidal ideation).
次要结局
- Rates of sustained remission and recurrence of suicide ideation(Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in SSI Scores(Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Response rate of depressive symptoms(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Remission rate of depressive symptoms(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Montgomery Asberg Depression Rating Scale (MADRS) Scores(Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Quick Inventory of Depressive Symptoms Self Report (QIDS-SR-16) Scores(Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Clinical Global Impressions (CGI) Scores(Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Short Form 12 Health Survey (SF-12) Scores(Baseline, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Sheehan Disability Scale (SDS) Scores(Baseline, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Digital Span Test (DST) Scores(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Digit Symbol Substitution Test (DSST) Scores(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Perceived Deficit Questionnaire for Depression 5-item (PDQ-D-5) Scores(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Young Mania Rating Scale (YMRS) Scores(Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in Clinician Administered Dissociative States Scale (CADSS) Scores(Baseline, after the 1st, 2nd, 3rd, 4th, 5th, and 6th esketamine treatments)
- Adverse event(Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12)
- Changes in neuroimaging metrics(Baseline, after the sixth treatments (week 2))
- Changes in Electroencephalogram (EEG) metrics(Baseline, after the first treatment, after the sixth treatments (week 2))
- Changes in biological indicators(Baseline, after the first treatment, after the sixth treatments (week 2))
- Remission rate of suicidal ideation(Baseline, after the first treatment, after the third treatment, at week 4, week 8, and week 12)
研究者
Gang Wang
President of Beijing Anding Hospital, Capital Medical University
Capital Medical University