CTIS2024-512210-18-00进行中（未招募）1 期
A prospective randomized, single blind, controlled, safety and non-inferiority study of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •male or female inpatients, age = 18 years, ICD-11 diagnosis of severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5), Hamilton Depression Rating Scale HAMD17 = 24, ability to understand and willingness to sign written informed consent document, negative urine pregnancy test in women, anesthesiological approval for ECT (Classification of the American Society of Anesthesiologists ASA = 3), antidepressant and antipsychotic medication in steady state for at least 7 days prior to first ECT treatment
排除标准
- •severe somatic or neurological disease (esp. current or previous history of intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction), current or past history of schizophrenia or schizoaffective disorder, clinical relevant abnormalities on a general physical examination and routine laboratory screening, pregnancy, breast feeding, known allergy to the study drugs or compounds of the latter
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