Trials / Active Not Recruiting

Active Not RecruitingNCT06941844

A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)

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 MM120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Emerge

Status: Active Not Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 149 (actual)

Sponsor: Definium Therapeutics US, Inc. · Industry
Sex: All
Age: 18 Years – 74 Years
Healthy volunteers: Not accepted

Summary

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Major Depressive Disorder - Emerge

Detailed description

The study will enroll approximately 140 adult men and women 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 MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Conditions

Major Depressive Disorder

Interventions

Type	Name	Description
OTHER	Placebo	A substance that is designed to have no therapeutic value
DRUG	MM120 (LSD D-Tartrate)	A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Timeline

Start date: 2025-04-14
Primary completion: 2026-11-01
Completion: 2027-05-01
First posted: 2025-04-24
Last updated: 2026-03-13

Locations

25 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06941844. Inclusion in this directory is not an endorsement.