A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend
1 other identifier
interventional
165
1 country
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 major-depressive-disorder
Started May 2026
Typical duration for phase_3 major-depressive-disorder
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2026
CompletedFirst Submitted
Initial submission to the registry
May 12, 2026
CompletedFirst Posted
Study publicly available on registry
May 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
May 22, 2026
May 1, 2026
1.3 years
May 12, 2026
May 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at 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.
Baseline to Week 6
Secondary Outcomes (27)
Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1
Week 12, Week 4, Week 2, and Week 1
MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period
Baseline to Week 12
MADRS remission (total score ≤10) at each timepoint assessed during the 12-week double-blind treatment period
Baseline to Week 12
Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period
Day 2 to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score
Baseline to Week 12
- +22 more secondary outcomes
Study Arms (3)
Arm 1 - Placebo
PLACEBO COMPARATORA substance that is designed to have no therapeutic value
Arm 2 - 50µg DT120
SHAM COMPARATORA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Arm 3 - 100µg DT120
EXPERIMENTALA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Lighthouse Psychiatry
Gilbert, Arizona, 85234, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, 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
Charter Research
Orlando, Florida, 32803, United States
CenExel Atlanta
Atlanta, Georgia, 30331, United States
CenExel Decatur
Decatur, Georgia, 30030, United States
CenExel Savannah
Savannah, Georgia, 31405, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Adams Clinical Boston
Boston, Massachusetts, 02116, United States
Adams Clinical Harlem
New York, New York, 10029, United States
Cleveland Clinic
Cleveland, Ohio, 44113, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Coastal Carolina Research
North Charleston, South Carolina, 29405, United States
Cedar Clinical Research
Draper, Utah, 84020, United States
Inner Space Research
Orem, Utah, 84058, United States
VA Portland Healthcare System
Vancouver, Washington, 98661, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Definium Therapeutics Clinical Trials Info Requests
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2026
First Posted
May 18, 2026
Study Start
May 10, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05