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Clinical Trials in the USA / NCT06941844
Active, not recruiting Phase 3

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

NCT06941844 · tracked via the Priya Life Science USA tracker
Sponsor
Definium Therapeutics US, Inc
Phase
Phase 3
Started
2025-04-14
Last updated
2026-08-28

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

PlaceboDT120 →

Placebo: A substance that is designed to have no therapeutic value

DT120: A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Study 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 - Emerge

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 — Baseline to Week 6
    The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.

Trial sites (22)

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

More Definium Therapeutics US, Inc. trials in the USA

A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) Recruiting
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama) Active, not recruiting
A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage) Active, not recruiting
A Phase 2A Trial of DT402 for Autism Spectrum Disorder Recruiting

Other trials for the same condition

Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY) Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium Recruiting
Fisher Wallace Neurostimulation & Depression Study Active, not recruiting
Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder Recruiting
A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06941844 on ClinicalTrials.gov ↗ ← All trials in the USA