2025-522784-15-00招募中2 期
A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults with Major Depressive Disorder
Draig Therapeutics Limited3 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- This will be assessed by reviewing the change in the participants score of the depression rating scale called Montgomery Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
To assess the effects of different dose levels of the study medicine DT-101 and placebo in the treatment of depressive symptoms in people with MDD.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Subject, Investigator, Monitor, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •The participant is able to understand and willing to provide written informed consent.
- •Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 65 years of age, inclusive at the time of signing the informed consent.
- •Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022). The current episode needs to be at least 6 weeks in duration prior to the screening visit.
排除标准
- •In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
- •Receipt of any investigational product within 24 weeks prior to Screening.
- •Use of St John’s wort is prohibited within 14 days before administration of the first dose of investigational product on Day 1 (Baseline) until last dose of study medication.
- •Blood donation or draw in excess of 400 mL within 2 months prior to Screening or plasma donation in excess of 50 mL within 30 days prior to Screening and through the duration of the study. Please refer to the study protocol for full list of exclusion criteria.
结局指标
主要结局
This will be assessed by reviewing the change in the participants score of the depression rating scale called Montgomery Åsberg Depression Rating Scale (MADRS)
This will be assessed by reviewing the change in the participants score of the depression rating scale called Montgomery Åsberg Depression Rating Scale (MADRS)
次要结局
未报告次要终点
研究者
Draig Therapeutics Ltd
Scientific
Draig Therapeutics Limited
研究点 (3)
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