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Clinical Trials in the USA / NCT07592689
Recruiting Phase 3

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

NCT07592689 · tracked via the Priya Life Science USA tracker
Sponsor
Definium Therapeutics US, Inc
Phase
Phase 3
Started
2026-05-10
Last updated
2026-10-23

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 - Ascend

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 (30)

FacilityCityRegionStatus
Preferred Research Partners, Inc. Little Rock Arkansas Recruiting
ATP Clinical Research Orange County Orange California Recruiting
Kadima Neuropsychiatry Institute San Diego California Recruiting
UCSF Department of Neurology San Francisco California Not Yet Recruiting
Psychedelic Science Institute Santa Monica California Recruiting
Mountain View Clinical Research, Inc Denver Colorado Recruiting
Clinical Neuroscience Solutions, LLC (Jacksonville) Jacksonville Florida Recruiting
K2 Medical Research (Maitland) Maitland Florida Recruiting
Clinical Neuroscience Solutions, LLC (Orlando) Orlando Florida Recruiting
Charter Research Orlando Florida Not Yet Recruiting
K2 Medical Research (Tampa) Tampa Florida Recruiting
CenExel - Atlanta Center for Medical Research Atlanta Georgia Recruiting
CenExel - iResearch Atlanta Decatur Georgia Recruiting
CenExel - iResearch Savannah Savannah Georgia Recruiting
Uptown Research Institute Chicago Illinois Recruiting
Adams Clinical Boston Boston Massachusetts Active Not Recruiting
Adams Clinical Watertown Boston Massachusetts Recruiting
Vitalix Clinical Worcester Massachusetts Recruiting
Arch Clinical Trials, LLC St Louis Missouri Recruiting
Redbird Research Las Vegas Nevada Recruiting
Adams Clinical Harlem New York New York Active Not Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Adams Clinical Philadelphia Philadelphia Pennsylvania Recruiting
Coastal Carolina Research North Charleston South Carolina Recruiting
Austin Clinical Trial Partners Austin Texas Recruiting
Cedar Clinical Research Draper Utah Recruiting
Inner Space Research Orem Utah Recruiting
Memory Clinic Inc. Bennington Vermont Recruiting
Seattle Neuropsychiatric Treatment Center Seattle Washington Not Yet Recruiting
VA Portland Healthcare System Vancouver Washington Not Yet Recruiting

More Definium Therapeutics US, Inc. trials in the USA

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 3 Trial of DT120 for Major Depressive Disorder (Emerge) 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 NCT07592689 on ClinicalTrials.gov ↗ ← All trials in the USA