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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

Who can join

Ages 18 to 74 · All sexes

Inclusion Criteria:

1. Diagnosis of MDD per DSM-5
2. Male or female aged 18 to 74
3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
4. MADRS Total Score ≥26
5. CGI-S Score ≥4

Exclusion Criteria:

1. Certain psychiatric disorders (other than major depressive disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
4. Any clinically significant unstable illness

About the study

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

What is being tested

• Placebo (other)
• DT120 (drug)

Sponsor: Definium Therapeutics US, Inc. · Participants: 165 · Started: May 10, 2026

Contact the study team

• Definium Therapeutics Clinical Trials Info Requests · Phone: 1-332-282-0479

Official record on ClinicalTrials.gov — NCT07592689

Locations in the U.S.

Conditions

• Major Depressive Disorder

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.