A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 42
研究概览
简要总结
A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Ascend
详细描述
The study will enroll approximately 165 participants aged 18 to 74 years, inclusive, with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of MDD, a minimum MADRS total score of at least 26 and a CGI-S score of at least 4 at Screening and Baseline without clinically relevant medical or psychiatric history.
The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week Extension Phase (EP) with opportunity for open-label treatment during which participants will be monitored and evaluated for potential retreatment with DT120 based on pre-specified safety and symptom severity criteria.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MDD per DSM-5
- •Male or female aged 18 to 74
- •Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
- •MADRS Total Score ≥26
- •CGI-S Score ≥4
排除标准
- •Certain psychiatric disorders (other than major depressive disorder)
- •First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
- •Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
- •Any clinically significant unstable illness
研究组 & 干预措施
Arm 1 - Placebo
A substance that is designed to have no therapeutic value
干预措施: Placebo (Other)
Arm 2 - 50µg DT120
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
干预措施: DT120 (Drug)
Arm 3 - 100µg DT120
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
干预措施: DT120 (Drug)
结局指标
主要结局
未指定
次要结局
- MADRS remission (total score ≤12) at each timepoint assessed during the 12-week double-blind treatment period(Baseline to Week 12)
- MADRS remission (total score ≤12) at each timepoint assessed during the 40-week open-label period(40-week open label period)