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

Running, not enrolling · 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 - Emerge

Key facts

Study ID

NCT06941844

Run by

Definium Therapeutics US, Inc.

People needed

149

Starts

2025-04-14

Expected to finish

2027-02-01

Last updated by the study team

2026-07-30

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
• Kadima Neuropsychiatry Institute — La Jolla, California, United States
• Psychedelic Science Institute — Santa Monica, California, United States
• Mountain View Clinical Research, Inc — Denver, Colorado, United States
• Clinical Neuroscience Solutions, Inc - Jacksonville — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc - Orlando — Orlando, Florida, United States
• Charter Research — Orlando, Florida, United States
• Uptown Research Institute (URI), LLC — Chicago, Illinois, United States
• Sheppard Pratt — Baltimore, Maryland, United States
• Adams Clinical Boston — Boston, Massachusetts, United States
• Adams Clinical — Watertown, Massachusetts, United States
• University of Missouri — Columbia, Missouri, United States
• Cenexel HRI — Berlin, New Jersey, United States
• Adams Clinical Harlem — New York, New York, United States
• Columbia - New York State Psychiatric Institute — New York, New York, United States
• Neuro-Behavioral Clinical Research — Canton, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States
• Clinical Neuroscience Solutions, Inc - Memphis — Memphis, Tennessee, United States
• Austin Clinical Trial Partners — Austin, Texas, United States
• Cedar Clinical Research — Murray, Utah, United States
• Memory Clinic, Inc — Bennington, Vermont, United States

Full record on ClinicalTrials.gov

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