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 人开始时间: 2019年4月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- •- 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.
- •- Stable dose of psychotropic drugs at screening
- •defined as no changes in dose or type of
- •antidepressants, antipsychotics, or mood stabilizers
- •for at least 2 weeks prior to randomization if applicable.
- •- No new antidepressant initiated 4 weeks or less
- •before baseline, and 6 weeks or less before baseline if
- •subject is initiated on fluoxetine
- •- At least one prior clinical depressive episode
- •(recurrent major depressive disorder).
- •- Able to communicate well, and to understand and
- •comply with study requirements
- •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 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
- •- Acute serious and/or imminent suicidal ideation
- •and/or intent within the prior 2 weeks, or any suicide
- •attempt within the prior 4 weeks at screening.
- •- Use of other investigational drugs at the time of
- •randomization, or within 30 days or 5 half-lives of
- •randomization, whichever was longer; or longer if
- •required by local regulations at baseline.
- •- Current pregnancy or lactation.
- •- Positive HIV, Hepatitis B or C test.
- •- Resting QTcF =450 msec (male) or =460 msec
- •(female) at pre-treatment baseline
- •- History of multiple and recurring allergies or allergy to
- •the investigational compound/compound class being
- •used in this study.
- •- History of malignancy of any organ system (other
- •than localized basal cell carcinoma of the skin or insitu
- •cervical cancer), treated or untreated, within the
- •past 3 years, regardless of whether there is evidence
- •of local recurrence or metastases.
- •- Women of child-bearing potential, defined as all
- •women physiologically capable of becoming pregnant,
- •unless they are using highly effective methods of
- •contraception during dosing and for 1 week after
- •stopping of investigational drug.
- •- History of hypersensitivity to any of the study
- •treatments or excipients or to drugs similar to chemical
- •- Current diagnosis of borderline personality disorder
- •or antisocial personality disorder, based on DSM-5
- •- Current acute depressive episode lasting longer than
- •two years continuously, defined as no two week or
- •longer period where depressive symptoms are
- •subsyndromal in severity for a full DSM-5 acute major
- •depressive episode.
- •- Considered by the investigator, for any other reason,
- •to be an unsuitable candidate for the study.
研究者
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