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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT07592689
Phase
PHASE3
Status
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 - Ascend

Key Dates

Start date
May 10, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1 - Placebo
    A substance that is designed to have no therapeutic value
  • Sham Comparator: Arm 2 - 50µg DT120
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
  • Experimental: Arm 3 - 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 ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Lighthouse PsychiatryGilbertArizona85234-
Preferred Research Partners, Inc.Little RockArkansas72211
Stacy Tierney
501-553-9987
Kadima Neuropsychiatry InstituteSan DiegoCalifornia92037
Alexiss Rivas
858-412-4130
UCSF Department of NeurologySan FranciscoCalifornia94158
Jennifer Mitchell
510-985-3522
Psychedelic Science InstituteSanta MonicaCalifornia90404
Ashley Ramos
310-341-2882
Mountain View Clinical Research, IncDenverColorado80209
Jessica Bryant
720-941-8894
K2 Medical Research (Maitland)MaitlandFlorida32751
Vanessa Carrillo
407-676-5252
Charter ResearchOrlandoFlorida32803
Sarahi Monsalve
407-337-1000
K2 Medical Research (Tampa)TampaFlorida33607
Karina Perez
813-800-5252
CenExel AtlantaAtlantaGeorgia30331
Denniel Brown
404-881-5800
CenExel DecaturDecaturGeorgia30030
Branden Freeman
404-537-1281
CenExel SavannahSavannahGeorgia31405
Katie McCants
912-744-0800
Uptown Research InstituteChicagoIllinois60640
Chloe Rzeppa
773-989-8313
Adams ClinicalBostonMassachusetts02472
Harrison Gillman
617-744-8542
Adams Clinical BostonBostonMassachusetts02116
Anotida Viazhero
617-934-5743
Vitalix ClinicalWorcesterMassachusetts01608
Rajvi Patel
413-363-5206
Arch Clinical Trials, LLCSt LouisMissouri63141
Erica Ehrhardt
314-282-3521
Redbird ResearchLas VegasNevada89119
Pam Pioquinto
702-577-2000
Adams Clinical HarlemNew YorkNew York10029
Ashli Pratt
917-423-6797
Cleveland ClinicClevelandOhio44113
Katelyn Schwesinger
440-728-6025
Adams Clinical PhiladelphiaPhiladelphiaPennsylvania19104
Elizabeth Huang
267-207-2511
Coastal Carolina ResearchNorth CharlestonSouth Carolina29405
Brandy Dreyer
843-856-3784
Austin Clinical Trial PartnersAustinTexas78737
Cara Fonken
512-521-0595
Cedar Clinical ResearchDraperUtah84020
Kye Cutrubus
801-369-4219
Inner Space ResearchOremUtah84058
Yohan Paitrault
801-871-5516
Seattle Neuropsychiatric Treatment CenterSeattleWashington98104
Libby Kell
206-467-6300
VA Portland Healthcare SystemVancouverWashington98661
Bianca Watt
503-781-1205

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