Recruiting

Phase 3

DT120A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)

Sponsor:

Definium Therapeutics US, Inc.

Code:

NCT07592689

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

DT120

Study Details

Brief 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

Conditions

Major Depressive Disorder

Study ID

NCT07592689

Start date

May 10, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Placebo

A substance that is designed to have no therapeutic value

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 and Locations

Central contacts

Definium Therapeutics Clinical Trials Info Requests

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

Locations

Preferred Research Partners, Inc.

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Stacy Tierney

501-553-9987 stierney@preferredresearchpartners.com

Kadima Neuropsychiatry Institute

Recruiting

San Diego, California, United States, 92037

Contacts

Alexiss Rivas

858-412-4130 alexissr@kadimanp.com

Psychedelic Science Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Ashley Ramos

310-378-0303 trialadmin@psychedelicsci.com

Mountain View Clinical Research, Inc

Recruiting

Denver, Colorado, United States, 80209

Contacts

Jessica Bryant

720-941-8894 jessica@mtnresearch.com

CenExel - Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Denniel Brown

404-881-5800 d.brown@cenexel.com

CenExel - iResearch Atlanta

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Branden Freeman

404-537-1281 b.freeman@cenexel.com

CenExel - iResearch Savannah

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Katie McCants

912-744-0800 k.mccants@cenexel.com

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Chloe Rzeppa

773-989-8313 crzeppa@uptownresearch.com

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Contacts

Anotida Viazhero

617-934-5743 aviazhero@adamsclinical.com

Adams Clinical Watertown

Recruiting

Boston, Massachusetts, United States, 02472

Contacts

Harrison Gillman

617-744-8542 hgillman@adamsclinical.com

Vitalix Clinical

Recruiting

Worcester, Massachusetts, United States, 01608

Contacts

Rajvi Patel

413-363-5206 rpatel@vitalixclinical.com

Redbird Research

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Pam Pioquinto

702-577-2000 pamela@redbird-research.com

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

Contacts

Ashli Pratt

917-423-6797 apratt@adamsclinical.com

Adams Clinical Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Elizabeth Huang

267-207-2511 ehuang@adamsclinical.com

Coastal Carolina Research

Recruiting

North Charleston, South Carolina, United States, 29405

Contacts

Brandy Dreyer

843-856-3784 brandy.dreyer@coastalcarolinaresearch.com

Austin Clinical Trial Partners

Recruiting

Austin, Texas, United States, 78737

Contacts

Cara Fonken

512-521-0595 cfonken@austinCTP.com

Cedar Clinical Research

Recruiting

Draper, Utah, United States, 84020

Contacts

Kye Cutrubus

801-369-4219 kye.cutrubus@numinusnetwork.com

Inner Space Research

Recruiting

Orem, Utah, United States, 84058

Contacts

Yohan Paitrault

801-871-5516 yohan@innerspaceresearch.com

More Information

Sponsor

Definium Therapeutics US, Inc.

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Definium Therapeutics US, Inc. on 2026-08-10.