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 MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Panorama
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 245
- 试验地点
- 67
- 主要终点
- Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12
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 Generalized Anxiety Disorder - Panorama
详细描述
The study will enroll up to 375 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM A total score of at least 20 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 GAD per DSM-5
- •Male or female aged 18 to 74
- •HAM-A Total Score ≥20
排除标准
- •Certain psychiatric disorders (other than generalized anxiety 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
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12
时间窗: Baseline to Week 12
The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
次要结局
- Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1(Week 8, Week 4, Week 2, and Week 1)
- HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period(Baseline to Week 12)
- HAM-A remission (total score ≤7) 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 -Montgomery-Åsberg Depression Rating Scale (MADRS) total score(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)
- HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period(40 week open label period)
- HAM-A remission (total score ≤7) 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 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 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)
- Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - Montgomery-Åsberg Depression Rating Scale (MADRS) total score(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)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI-SHP(Baseline to Week 52)