jRCT2031240035招募中不适用
A Phase II, 6-week, multi-centre, randomised, double-blind (participant and investigator), placebo-controlled, dose-finding trial to evaluate the efficacy, tolerability, and safety of different doses of oral BI 1569912 as adjunctive therapy in patients with major depressive disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Established diagnosis of MDD with a duration of current depressive episode >= 8 weeks at the time of screening visit
- •Hamilton Depression Rating Scale 17 - Severity scale score >17
- •A documented ongoing monotherapy treatment of >= 6 weeks at the randomization visit, with an SSRI or SNRI at adequate dose
- •In the current episode, participants have shown insufficient treatment response
- •Male and female participants, 18 to 65 years of age at the time of consent.
- •Women who are of childbearing potential must be able and willing, to use two methods of contraception.
排除标准
- •Had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder
- •Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features
- •Any other personality disorder that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator.
- •Diagnosis of any other mental disorder that was the primary focus of treatment within 6 months prior to screening
- •A current or recent history of clinically significant suicidal ideation with intent within the past 3 months or a suicidal attempt within the past year
- •Diagnosis of a moderate to severe substance related disorder within 6 months prior to consent (with exception of caffeine and tobacco).
- •Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine)
- •Have started psychotherapy or other non-drug therapies (e.g. acupuncture, hypnosis) within 3 months prior to consent or plan to start at any time during the study
- •Use of alternative or traditional medicine (e.g. Chinese traditional medicine, herbal medication, St. John's wort etc.) within 14 days prior to randomization and during the entire course of the study
- •Use of NMDA inhibitors (including ketamine/esketamine) for the current ongoing depressive episode or any past treatment failure with ketamine.
- •Use of psychotropic medication, outside of ongoing SSRI/SNRI monotherapy and certain exceptions, which was not discontinued at least 5 half-lives prior to randomization.
结局指标
主要结局
-
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 8
次要结局
未报告次要终点
研究者
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