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

ClinicalTrials.gov ID

NCT07592689

Lead Sponsor

Definium Therapeutics US, Inc.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

165Estimated

Last Update Posted

Aug 10, 2026Actual

Start Date

May 10, 2026Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Jun 2028Estimated

Official Title

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend

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

Detailed Description

The study will enroll approximately 165 participants aged 18 to 74 years, inclusive, with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of MDD, a minimum MADRS total score of at least 26 and a CGI-S score of at least 4 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week Extension Phase (EP) with opportunity for open-label treatment during which participants will be monitored and evaluated for potential retreatment with DT120 based on pre-specified safety and symptom severity criteria.

• Major Depressive Disorder

• Placebo
• DT120

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Definium Therapeutics US, Inc.INDUSTRY

sarahi.monsalve@charterresearch.com407-337-1000

pamela@redbird-research.com702-577-2000

apratt@adamsclinical.com917-423-6797

schwesk@ccf.org440-728-6025

kye.cutrubus@numinusnetwork.com801-369-4219

yohan@innerspaceresearch.com801-871-5516

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

  NCT06941844

  Active, not recruitingInterventionalPhase 3Updated Aug 28, 2026
• A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)

  NCT06741228

  Active, not recruitingInterventionalPhase 3Updated Sep 2, 2026
• A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression

  NCT07300969

  RecruitingInterventionalPhase 2Updated Aug 26, 2026
• A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

  NCT07610473

  RecruitingInterventionalPhase 2Updated Sep 2, 2026
• A Study of MD-120 in Patients With Depression

  NCT04345471

  CompletedInterventionalPhase 3Updated Feb 29, 2024
• A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

  NCT06809595

  Active, not recruitingInterventionalPhase 3Updated Sep 4, 2026