RecruitingPhase 3

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

United States165 participantsStarted 2026-05-10

Plain-language 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

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is measuring improvement on the MADRS depression scale after 6 weeks on DT120, how does that timeline compare to how long my current or planned treatment would take to show results?
2Because this is a Phase 3 trial, there's already earlier-phase safety data on DT120 — would you be able to walk me through what's known so far about its side effects and how it compares to antidepressants I might already be familiar with?
3If I were to join this trial, is there a chance I could be assigned to a placebo group, and if so, what would happen to my depression care during those 6 weeks?
4Would you consider my current situation — including any medications I'm already taking or previous treatments I've tried — to be a good fit for what this trial is looking for, or would standard treatment options be a more appropriate first step for me?
5If DT120 doesn't work for me during the trial or I need to stop early, what other treatment options would still be available to me afterward?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6

Timeframe: Baseline to Week 6

Trial details

NCT IDNCT07592689

SponsorDefinium Therapeutics US, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Definium Therapeutics Clinical Trials Info Requests

1-332-282-0479 clinicaltrials@definiumtx.com

View on ClinicalTrials.gov More Major Depressive Disorder trials