2025-522308-25-00招募中3 期
J2S-MC-GZMH: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 14
- 主要终点
- Time to Relapse Defined as the Number of Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
研究概览
简要总结
To demonstrate that at least 1 dose level of brenipatide, given as an adjunctive treatment to a stable SoC medication regimen, is superior to placebo in the treatment of participants with MDD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for major depressive disorder
- •Be on stable standard of care for major depressive disorder
- •Be reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as • self-inject study intervention • store and use the provided blinded study intervention, as directed • maintain electronic and paper study diaries, as applicable, and • complete the required questionnaires
排除标准
- •Have ever a diagnosis of the following: • schizophrenia or other psychotic disorder • bipolar disorder • borderline personality disorder, or • any eating disorder
- •Have type 1 diabetes mellitus, or a history of • ketoacidosis, or • hyperosmolar state or coma
- •Have evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- •Be actively suicidal or deemed a significant risk for suicide
- •Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
结局指标
主要结局
Time to Relapse Defined as the Number of Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
Time to Relapse Defined as the Number of Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (14)
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