Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- MADRS score
研究概览
简要总结
Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide.
Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms.
To the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI).
In this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the Structured Clinical Interview for the DSM-V (SCID-V).
- •MADRS score ≥ 25
- •Pharmacologically treatment-resistant depressive episode [Stage ≥ II, defined by Thase & Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (≥ 4 weeks each)] (88).
- •Age: 18 - 50 years
- •Written informed consent
排除标准
- •Participation in another interventional clinical trial
- •Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy:
- •Patients who meet any exclusion criteria for nasal esketamine treatment as described in the clinical guidelines
- •Contraindications to the conduction of MRI
- •History of one or more of the following diagnoses (DSM-5):
- •MDD, single or recurrent episode with psychotic features (296.24; 296.34)
- •past or current substance dependence (except caffeine, nicotine) (303.x, 304.x, 305.x)
- •neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x)
- •schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x)
- •neurocognitive disorders (290.x, 292.x, 294.x, 331.x).
- •history of ECT (unsuccessful or successful)
- •suicidal tendency requiring admission in a locked ward
- •pregnancy or lactation period
- •lack of anesthetic clearance for any other reason
- •insufficient command of German language.
研究组 & 干预措施
Intranasal Esketamine
干预措施: Esketamine nasal spray (Drug)
ECT
干预措施: Electroconvulsive therapy (Procedure)
结局指标
主要结局
MADRS score
时间窗: 4 weeks
Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as \>50% reduction in score
次要结局
未报告次要终点