jRCT2061240061进行中（未招募）不适用
A 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 in patients with major depressive disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 222
- 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
- •Male and female participants, 18 to 65 years of age
- •Women who are of childbearing potential (WOCBP) must be able and willing, to use two methods of contraception
- •Established diagnosis of MDD, single episode or recurrent with a duration of current depressive episode more than equal to 8 weeks and less than equal to 24 months at the time of randomisation
- •Hamilton Depression Rating Scale 17 (HDRS 17) - Severity score 20 and over
- •Clinical Global Impression Severity Scale (CGI S) score 4 and over
排除标准
- •Have 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 at the time of screening visit. 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, as per clinical discretion of the investigator
- •Treatment failure to 2 or more antidepressants in the current episode
- •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
- •Participants with a body mass index (weight (kg) / height (m)2) lower than 18 kg / m2 or greater than 40 kg / m2 at screening
- •Diagnosis of a moderate to severe substance related disorder within 6 months prior to screening visit (with exception of caffeine and tobacco)
- •Frequent use of benzodiazepines
- •Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) at screening. Participants with positive cannabis and benzodiazepine tests can be included if the investigator confirms that there is no moderate to severe substance related disorder or chronic benzodiazepine use
- •Have started psychotherapy or other non drug therapies (e.g. acupuncture, hypnosis) within 3 months prior to screening or plan to start at any time during 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 (including antidepressant and antipsychotic therapy) which was not discontinued at least 5 half lives prior to randomization
- •Prior use of any investigational product within 6 months prior to randomization
- •Have failed a 3rd party eligibility assessment within the 6 months prior screening
- •Known history of HIV infection and/or a positive result for an active Hepatitis B or C infection
结局指标
主要结局
-
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6
次要结局
未报告次要终点
研究者
相似试验
招募中
1 期
A study to test different doses of BI 1831169 alone and in combination with an anti-PD-1 antibody in people with different types of advanced cancer (solid tumors).2024-512504-19-00Boehringer Ingelheim International GmbH97
招募中
1 期
A study to test different doses of BI 765049 in people with advanced cancer of the colon, rectum, stomach, or pancreas2024-519301-36-00Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.40
招募中
1 期
A study to test how well different doses of BI 764532 are tolerated by people with a tumour in the brain that is positive for DLL32022-501766-22-01Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG14
招募中
1 期
A study to test how different doses of BI 1703880 in combination with ezabenlimab are tolerated in people with different types of advanced cancer (solid tumours)2024-511501-37-00Boehringer Ingelheim International GmbH18
已完成
1 期
A study to test how well multiple doses of BI 765423 are tolerated by healthy men2023-506722-36-00Boehringer Ingelheim International GmbH60