EUCTR2020-004172-17-AT进行中（未招募）1 期
Electroconvulsive therapy vs. esketamine nasal spray in treatment-resistant depression: a longitudinal, randomized efficacy comparison pilot study - ETES
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the SCID-5-CV Interview
- •2. MADRS score = 25
- •3. 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)]
- •4. Age: 18 - 50 years
- •5. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Participation in another interventional clinical trial
- •2. Relative contraindications to ECT treatment: Neurodegenerative disease e.g. stroke, epilepsy, severe traumatic brain injury, intracranial aneurysm (>7 mm) except small meningioma; acute cardiac disease (<3 months) or chronic heart disease; not organized deep venous thrombosis; autoimmune disease with brain involvement; pheochromocytoma; ablatio retinae; family anamnesis for epilepsy; other clinical contraindications
- •3. Patients who meet any exclusion criteria for nasal esketamine treatment: Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation; history of intracerebral hemorrhage; hypersensitivity to esketamine, ketamine, or any of the excipients.
- •4. Contraindications to the conduction of MRI: claustrophobia; metal, electric, magnetic, or mechanically driven implants; tattoos on head or neck
- •5. 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).
- •6. history of ECT (unsuccessful or successful)
- •7. suicidal ideation
- •8. pregnancy or lactation period
- •9. lack of anesthetic clearance for any other reason
- •10. insufficient command of German language.
研究者
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