Phase 3 DT120 for Major Depressive Disorder (Ascend)

This study is testing a new drug called DT120 for Major Depressive Disorder (MDD). DT120 works by affecting a specific receptor in the brain called serotonin 2A (5-HT2A). Researchers want to see if DT120 can improve symptoms of depression compared to a placebo (a substance with no active medicine). You might be able to join if you are 18 to 74 years old, have been diagnosed with MDD, and have been experiencing a depressive episode for at least 8 weeks but no more than 24 months. We will measure changes in your depression symptoms using a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks to see if the treatment is successful. The current status of this study is unclear.

Study design
This is a Phase 3, double-blind (meaning neither you nor your doctor will know if you're getting DT120 or placebo), placebo-controlled study with about 165 participants. It includes an open-label extension where all participants receive DT120.
What's involved
You would participate in a 12-week randomized treatment period, followed by a 40-week extension phase where you might receive DT120.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured at Week 6, and you will be monitored and evaluated for potential retreatment with DT120 during the 40-week extension phase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07592689

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

Recruiting
PHASE3Ages 18–74InterventionalTreatment
Definium Therapeutics US, Inc.
~165 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:PlaceboDT120

At a glance

Recruiting sites
18 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
Measured over Baseline to Week 6
Major Depressive Disorder
30 sites across 17 states
Florida5
California4
Georgia3
Massachusetts3
Utah2
Washington2
Arkansas1
Colorado1
Definium Therapeutics Clinical Trials Info Requests
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  • Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6Baseline 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.