A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
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 Major Depressive Disorder - Ascend
Definium Therapeutics US, Inc.
165 participants
May 10, 2026
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
A substance that is designed to have no therapeutic value
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT07592689