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RecruitingPhase 3

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

NCT07592689 · Definium Therapeutics US, Inc.

Recruiting
Status
Accepting participants
Phase 3
Phase
165
Target enrolment
30
Study sites
17 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over Baseline to Week 6

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 74 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

30 study sites

FacilityCityRegionCountry
Preferred Research Partners, Inc.Little RockArkansasUnited States
ATP Clinical Research Orange CountyOrangeCaliforniaUnited States
Kadima Neuropsychiatry InstituteSan DiegoCaliforniaUnited States
UCSF Department of NeurologySan FranciscoCaliforniaUnited States
Psychedelic Science InstituteSanta MonicaCaliforniaUnited States
Mountain View Clinical Research, IncDenverColoradoUnited States
Clinical Neuroscience Solutions, LLC (Jacksonville)JacksonvilleFloridaUnited States
K2 Medical Research (Maitland)MaitlandFloridaUnited States
Clinical Neuroscience Solutions, LLC (Orlando)OrlandoFloridaUnited States
Charter ResearchOrlandoFloridaUnited States
K2 Medical Research (Tampa)TampaFloridaUnited States
CenExel - Atlanta Center for Medical ResearchAtlantaGeorgiaUnited States
CenExel - iResearch AtlantaDecaturGeorgiaUnited States
CenExel - iResearch SavannahSavannahGeorgiaUnited States
Uptown Research InstituteChicagoIllinoisUnited States
Adams Clinical BostonBostonMassachusettsUnited States
Adams Clinical WatertownBostonMassachusettsUnited States
Vitalix ClinicalWorcesterMassachusettsUnited States
Arch Clinical Trials, LLCSt LouisMissouriUnited States
Redbird ResearchLas VegasNevadaUnited States
Adams Clinical HarlemNew YorkNew YorkUnited States
Cleveland ClinicClevelandOhioUnited States
Adams Clinical PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Coastal Carolina ResearchNorth CharlestonSouth CarolinaUnited States
Austin Clinical Trial PartnersAustinTexasUnited States
Cedar Clinical ResearchDraperUtahUnited States
Inner Space ResearchOremUtahUnited States
Memory Clinic Inc.BenningtonVermontUnited States
Seattle Neuropsychiatric Treatment CenterSeattleWashingtonUnited States
VA Portland Healthcare SystemVancouverWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07592689 on ClinicalTrials.gov →

Last updated in the registry 2026-08-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 7 trials from Definium Therapeutics US, Inc. →