NCT06941844进行中（未招募）3 期
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 - Emerge
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
- 试验地点
- 50
- 主要终点
- Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
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 - Emerge
详细描述
The study will enroll approximately 140 adult men and women 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 with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment 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 2 - 100µg DT120
Experimental
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 1 - Placebo
Placebo Comparator
A substance that is designed to have no therapeutic value
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
时间窗: Baseline to Week 6
The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.
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)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - Work Productivity and Activity Impairment Specific Health Problem Questionnaire (WPAI-SHP)(Baseline to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L)(Baseline to Week 12)
- Percent of participants requiring one, two, three, four, or five doses of DT120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period(Day 1 to Week 52)
- Need for DT120 treatment as assessed by the average number of DT120 treatments during the study(Day 1 to Week 52)
- MADRS remission (total score ≤12) at each timepoint assessed during the 40-week open-label period(40-week open label period)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI-SHP(Baseline to Week 52)
- Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1(Week 12, Week 4, Week 2, and Week 1)
- MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period(Baseline to Week 12)
- MADRS remission (total score ≤10) at each timepoint assessed during the 12-week double-blind treatment period(Baseline to Week 12)
- Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period(Day 2 to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score(Baseline to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score(Baseline to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in MADRS-6(Baseline to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Hamilton Anxiety Rating Scale (HAM-A)(Baseline to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Work Productivity and Activity Impairment Questionnaire (WPAI)(Baseline to Week 12)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L)(Baseline to Week 12)
- Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period(Baseline to Week 12)
- Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period(Baseline to Week 12)
- Percent of participants requiring one, two, three, four, or five doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period(Day 1 to Week 52)
- Time to first treatment or lack of efficacy in the open-label period (Part B)(Day 1 to Week 52)
- Need for MM120 treatment as assessed by the average number of MM120 treatments during the study(Day 1 to Week 52)
- MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period(40-week open label period)
- MADRS remission (total score ≤10) at each timepoint assessed during the 40-week open-label period(40-week open label period)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score(Baseline to Week 52)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score(Baseline to Week 52)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score(Baseline to Week 52)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS-6 total score(Baseline to Week 52)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in HAM-A total score(Baseline to Week 52)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI(Baseline to Week 52)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L(Baseline to Week 52)
- CSFQ-14 total score at each timepoint assessed during the open-label period(40 week open label period)
- Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period(40 week open label period)
研究者
研究点 (50)
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