EUCTR2018-003002-12-ES
进行中（未招募）
1 期
A multi-center, randomized, subject and investigator-blinded,placebo-controlled, active comparator, parallel-groupproof of concept study to evaluate the efficacy,safety, tolerability, and pharmacokinetics of MIJ821 inpatients with treatment-resistant depression - Study of efficacy and safety of MIJ821 in treatment-resistant depression patients
ovartis Farmacéutica, S.A.0 个研究点目标入组 70 人2019年4月12日
相关药物KETOLAR
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ovartis Farmacéutica, S.A.
- 入组人数
- 70
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Signed informed consent.
- •\- Male and female subjects, 18 to 65 years of age
- •(inclusive) at screening.
- •\- DSM\-5 defined major depressive episode at the time
- •of screening
- •\- Montgomery\-Åsberg Depression Rating Scale
- •(MADRS) score \= 24 at baseline
- •\- Failure to respond to two or more antidepressant
- •treatments, at least one of which is in the current
- •depressive episode, with adequate dose and duration.
排除标准
- •\- Any prior or current diagnosis of bipolar disorder,
- •schizophrenia, or schizoaffective disorder at screening.
- •\- Current alcohol or substance use (other than nicotine
- •or caffeine) meeting DSM\-5 criteria for addiction,
- •within the past month.
- •\- Prior suicidality caused by or associated with
- •ketamine, as identified by prior psychiatric history
- •assessed by the investigator, and augmented by
- •medical records and third party report (family, friends,
- •clinician\-treaters) where available.
结局指标
主要结局
未指定
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