A Phase 3 Randomized, Double-blind, Placebo-controlled 12-Week Study With a 40-Week Open-label Extension Evaluating Oral DT120 In Adults With Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the effects of DT120, a psychoactive substance targeting the serotonin 2A receptor, in adults diagnosed with Major Depressive Disorder (MDD). This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of DT120 in people aged 18 to 74 years who have a confirmed diagnosis of MDD with significant depression severity. The study includes a 12-week treatment period where participants receive a single dose of either DT120 at two different doses or a placebo. This is followed by a 40-week open-label extension phase where participants may receive additional DT120 treatment based on safety and symptom evaluations. The study design allows careful monitoring of treatment effects and possible retreatment needs over a total period of 52 weeks. Participants will undergo regular assessments including depression rating scales such as the Montgomery-Åsberg Depression Rating Scale (MADRS) at multiple time points, clinical global impression scores, anxiety scales, quality of life questionnaires, and sexual functioning evaluations. These measures will help track changes in depression symptoms and overall well-being. Safety and treatment effects will be closely monitored throughout both study phases to understand the impact of DT120 over time.

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