A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
Recruiting · NCT07592689 · Interventional (participants receive a specific treatment) · Lead sponsor: Definium Therapeutics US, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
DT120Placebo
What this trial is about
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
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
30 locations listed across 17 US states.
- Preferred Research Partners, Inc. - Little Rock, Arkansas, United States
- ATP Clinical Research Orange County - Orange, California, United States
- Kadima Neuropsychiatry Institute - San Diego, California, United States
- UCSF Department of Neurology - San Francisco, California, United States
- Psychedelic Science Institute - Santa Monica, California, United States
- Mountain View Clinical Research, Inc - Denver, Colorado, United States
- Clinical Neuroscience Solutions, LLC (Jacksonville) - Jacksonville, Florida, United States
- K2 Medical Research (Maitland) - Maitland, Florida, United States
- Clinical Neuroscience Solutions, LLC (Orlando) - Orlando, Florida, United States
- Charter Research - Orlando, Florida, United States
- K2 Medical Research (Tampa) - Tampa, Florida, United States
- CenExel - Atlanta Center for Medical Research - Atlanta, Georgia, United States
- CenExel - iResearch Atlanta - Decatur, Georgia, United States
- CenExel - iResearch Savannah - Savannah, Georgia, United States
- Uptown Research Institute - Chicago, Illinois, United States
- Adams Clinical Boston - Boston, Massachusetts, United States
- Adams Clinical Watertown - Boston, Massachusetts, United States
- Vitalix Clinical - Worcester, Massachusetts, United States
- Arch Clinical Trials, LLC - St Louis, Missouri, United States
- Redbird Research - Las Vegas, Nevada, United States
- Adams Clinical Harlem - New York, New York, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Adams Clinical Philadelphia - Philadelphia, Pennsylvania, United States
- Coastal Carolina Research - North Charleston, South Carolina, United States
- Austin Clinical Trial Partners - Austin, Texas, United States
- Cedar Clinical Research - Draper, Utah, United States
- Inner Space Research - Orem, Utah, United States
- Memory Clinic Inc. - Bennington, Vermont, United States
- Seattle Neuropsychiatric Treatment Center - Seattle, Washington, United States
- VA Portland Healthcare System - Vancouver, Washington, United States