Overview
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
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
