Phase 3 Study of Oral DT120 Compared to Placebo for Adults with Major Depressive Disorder 12-Week Double-Blind Treatment Followed by 40-Week Open-Label Extension

What this Trial Is About

Researchers are conducting a Phase 3 clinical trial to evaluate the drug DT120 compared to placebo in adults aged 18 to 74 years diagnosed with Major Depressive Disorder MDD. Participants must have a confirmed diagnosis according to the DSM-5, be experiencing a major depressive episode lasting between 8 weeks and 24 months, and have certain minimum scores on depression severity scales. The study aims to assess the efficacy and safety of DT120 in treating MDD symptoms. The study includes a 12-week randomized, double-blind period where participants receive a single dose of either DT120 or placebo. After this, eligible participants can enter a 40-week open-label extension phase where all receive DT120 and are monitored for safety and symptom changes, with the possibility of retreatment based on specific criteria. The study drug works mainly through serotonin 2A receptor activity. Participants will undergo various assessments throughout the study, including regular evaluations of depression severity using the Montgomery-sberg Depression Rating Scale MADRS, Clinical Global Impression scales, anxiety rating, quality of life questionnaires, and sexual functioning assessments. The primary outcome is the change in MADRS score at Week 6. Safety and treatment needs will also be monitored during the extension phase. Total participation may last up to 52 weeks, with ongoing monitoring of mood and symptom changes.

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