A Phase II, 6-week, Multicenter, Randomized, Double Blind (Patient and Investigator) or Masked, Placebo Controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 as Adjunctive Therapy in MD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 53
- 主要终点
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
研究概览
简要总结
This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.
Participants continue their standard therapy throughout the study.
Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.
Participants are in the study for about 2 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms.
The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 1569912 low dose group
干预措施: BI 1569912 (Drug)
BI 1569912 medium dose group
干预措施: BI 1569912 (Drug)
BI 1569912 high dose group
干预措施: BI 1569912 (Drug)
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
时间窗: at baseline, at week 6
The MADRS evaluates core symptoms of depression. It is a clinician-rated measure of depression severity and consists of 10 items. MADRS items are rated on a 0-6 continuum (0 = no abnormality, 6 = severe). The possible total score could range from 0 to 60 - from normal with absence of symptoms to severe depression.
次要结局
- Change from baseline in MADRS total score at Day 8(at baseline, at day 8)
- Response defined as ≥50% MADRS reduction from baseline at Day 8(at baseline, at day 8)
- Response defined as ≥50% MADRS reduction from baseline at Week 6(at baseline, at week 6)
- Remission defined as MADRS total score ≤10 at Week 6(up to 6 weeks)
- Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8(at baseline, at day 8)
- Change from baseline in SMDDS total score at Week 4(at baseline, at week 4)