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Active, not recruitingPhase 3

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

NCT06941844 · Definium Therapeutics US, Inc.

Closed to entry
Status
Not accepting participants
Phase 3
Phase
149
Target enrolment
22
Study sites
16 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 - Emerge

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

22 study sites

FacilityCityRegionCountry
Preferred Research Partners, IncLittle RockArkansasUnited States
Kadima Neuropsychiatry InstituteLa JollaCaliforniaUnited States
Psychedelic Science InstituteSanta MonicaCaliforniaUnited States
Mountain View Clinical Research, IncDenverColoradoUnited States
Clinical Neuroscience Solutions, Inc - JacksonvilleJacksonvilleFloridaUnited States
Clinical Neuroscience Solutions, Inc - OrlandoOrlandoFloridaUnited States
Charter ResearchOrlandoFloridaUnited States
Uptown Research Institute (URI), LLCChicagoIllinoisUnited States
Sheppard PrattBaltimoreMarylandUnited States
Adams Clinical BostonBostonMassachusettsUnited States
Adams ClinicalWatertownMassachusettsUnited States
University of MissouriColumbiaMissouriUnited States
Cenexel HRIBerlinNew JerseyUnited States
Adams Clinical HarlemNew YorkNew YorkUnited States
Columbia - New York State Psychiatric InstituteNew YorkNew YorkUnited States
Neuro-Behavioral Clinical ResearchCantonOhioUnited States
University of CincinnatiCincinnatiOhioUnited States
Adams Clinical PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Clinical Neuroscience Solutions, Inc - MemphisMemphisTennesseeUnited States
Austin Clinical Trial PartnersAustinTexasUnited States
Cedar Clinical ResearchMurrayUtahUnited States
Memory Clinic, IncBenningtonVermontUnited 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.

NCT06941844 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. →