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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT07592689

Run by

Definium Therapeutics US, Inc.

People needed

165

Starts

2026-05-10

Expected to finish

2028-06-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States (enrolling)
• CenExel - iResearch Savannah — Savannah, Georgia, United States (enrolling)
• Uptown Research Institute — Chicago, Illinois, United States (enrolling)
• Adams Clinical Boston — Boston, Massachusetts, United States (enrolling)
• Adams Clinical Watertown — Boston, Massachusetts, United States (enrolling)
• Vitalix Clinical — Worcester, Massachusetts, United States (enrolling)
• Redbird Research — Las Vegas, Nevada, United States (enrolling)
• Adams Clinical Harlem — New York, New York, United States (enrolling)
• Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Coastal Carolina Research — North Charleston, South Carolina, United States (enrolling)
• Austin Clinical Trial Partners — Austin, Texas, United States (enrolling)
• Cedar Clinical Research — Draper, Utah, United States (enrolling)
• Inner Space Research — Orem, Utah, United States (enrolling)
• Kadima Neuropsychiatry Institute — San Diego, California, United States (enrolling)
• Psychedelic Science Institute — Santa Monica, California, United States (enrolling)
• Mountain View Clinical Research, Inc — Denver, Colorado, United States (enrolling)
• CenExel - Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• CenExel - iResearch Atlanta — Decatur, Georgia, United States (enrolling)
• ATP Clinical Research Orange County — Orange, California, United States
• Arch Clinical Trials, LLC — St Louis, Missouri, United States
• UCSF Department of Neurology — San Francisco, California, United States
• VA Portland Healthcare System — Vancouver, Washington, United States
• Memory Clinic Inc. — Bennington, Vermont, United States
• Clinical Neuroscience Solutions, LLC (Jacksonville) — Jacksonville, Florida, United States
• K2 Medical Research (Maitland) — Maitland, Florida, United States

Full record on ClinicalTrials.gov

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