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A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
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
ClinicalTrials.gov IDNCT07592689
PhasePHASE3
Enrollment165
SponsorDefinium Therapeutics US, Inc.
Age18 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
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
Interventions
- Other: Placebo — A substance that is designed to have no therapeutic value
- Drug: DT120 — A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Primary outcomes
- Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (Baseline to Week 6)
Eligibility information
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
Study locations
- Preferred Research Partners, Inc., Little Rock, Arkansas 72211 United States
- ATP Clinical Research Orange County, Orange, California 92866 United States
- Kadima Neuropsychiatry Institute, San Diego, California 92037 United States
- UCSF Department of Neurology, San Francisco, California 94158 United States
- Psychedelic Science Institute, Santa Monica, California 90404 United States
- Mountain View Clinical Research, Inc, Denver, Colorado 80209 United States
- Clinical Neuroscience Solutions, LLC (Jacksonville), Jacksonville, Florida 32256 United States
- K2 Medical Research (Maitland), Maitland, Florida 32751 United States
- Clinical Neuroscience Solutions, LLC (Orlando), Orlando, Florida 32801 United States
- Charter Research, Orlando, Florida 32803 United States
Showing 10 of 30 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.