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 Generalized Anxiety Disorder - Voyage
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 214
- 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 - Voyage
详细描述
The study will enroll up to 200 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)
盲法说明
This study is double-blinded, which means that both the participants and the treating clinicians will be masked to treatment allocation, meaning neither party will know which participants are receiving the active drug and which are receiving the placebo. The placebo tablet is identical looking to the active drug
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 - 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)
- Need for DT120 treatment as assessed by the average number of DT120 treatments during the study(Day 1 to Week 52)
- 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)
- Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI-SHP(Baseline to Week 52)