EUCTR2011-005992-17-BE进行中（未招募）1 期
A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects with Treatment-Resistant Depression
适应症
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
- •- Be a man or woman, 18 to 64 years of age, inclusive.
- •- Be medically stable on the basis of clinical laboratory tests performed at screening.
- •- Meet Diagnostic and Statistical Manual of Mental Disorders – Fourth Edition (DSM-IV-TR) diagnostic criteria for recurrent MDD, without psychotic features (DSM-IV, 296.32, or 296.33),
- •- Have an inadequate response to at least 1 antidepressant in the current episode of depression and at least one other inadequate treatment response to an antidepressant either in the current episode or in a previous episode.
- •- Have an IDS-C30 total score = 34 at Screening and Day -1.
- •- Hospitalized or agreed to be hospitalized from Day -1 through the completion of study procedures on Day 2 and from Day 3 through the completion of study procedures on Day 4.
- •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
排除标准
- •- Has a history of, or current signs and symptoms of, liver or renal insufficiency; hypothyroidism or hyperthyroidism, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled may participate in the study.
- •- Has uncontrolled hypertension (SBP> 160 mmHg or DBP > 90 mmHg despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment) at Screening; or any past history of hypertensive crisis.
- •- Has a history of previous non-response of depressive symptoms to ketamine/esketamine.
- •- Has any contraindication to the use of esketamine, per local prescribing information.
- •- Has not responded to previous treatment with electroconvulsive therapy (ECT).
研究者
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