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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT06941844
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — OTHER
    A substance that is designed to have no therapeutic value
  • DT120 — DRUG
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Study Details

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

Key Dates

First listed
Apr 24, 2025
Start date
Apr 14, 2025
Status verified
Jul 2026
Primary completion
May 20, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
149 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1 - Placebo
    A substance that is designed to have no therapeutic value
  • Experimental: Arm 2 - 100µg DT120
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Primary Outcome Measure

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 [ Time Frame: Baseline to Week 6 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Preferred Research Partners, IncLittle RockArkansas72211-
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
Psychedelic Science InstituteSanta MonicaCalifornia90404-
Mountain View Clinical Research, IncDenverColorado80209-
CNS, LLC (Jacksonville)JacksonvilleFlorida32256-
Charter ResearchOrlandoFlorida32803-
CNS, LLC (Orlando)OrlandoFlorida32801-
Uptown Research Institute (URI), LLCChicagoIllinois60640-
Sheppard PrattBaltimoreMaryland21204-
Adams Clinical BostonBostonMassachusetts02116-
Adams ClinicalWatertownMassachusetts02472-
University of MissouriColumbiaMissouri65212-
Cenexel HRIBerlinNew Jersey08053-
Adams Clinical HarlemNew YorkNew York10029-
Columbia - New York State Psychiatric InstituteNew YorkNew York10032-
Neuro-Behavioral Clinical ResearchCantonOhio44720-
University of CincinnatiCincinnatiOhio45219-
Adams Clinical PhiladelphiaPhiladelphiaPennsylvania19104-
CNS, LLC (Memphis)MemphisTennessee38119-
Austin Clinical Trial PartnersAustinTexas78737-
Cedar Clinical ResearchMurrayUtah84020-
Memory Clinic, IncBenningtonVermont05201-

Find similar trials in Little Rock, AR

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By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Preferred Research Partners, Inc· Little Rock, ARKadima Neuropsychiatry Institute· La Jolla, CAPsychedelic Science Institute· Santa Monica, CAMountain View Clinical Research, Inc· Denver, COCNS, LLC (Jacksonville)· Jacksonville, FLCharter Research· Orlando, FL

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