A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)

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.

• Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1 [Срок оценки: 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 [Срок оценки: Baseline to Week 12]
• MADRS remission (total score ≤12) at each timepoint assessed during the 12-week double-blind treatment period [Срок оценки: Baseline to Week 12]
• Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline to Week 12]
• Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in MADRS-6 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Baseline to Week 12]
• Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period [Срок оценки: Baseline to Week 12]