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

RECRUITINGPhase 3Sponsored by Definium Therapeutics US, Inc.
Actively Recruiting
PhasePhase 3
SponsorDefinium Therapeutics US, Inc.
Started2025-04-14
Est. completion2026-11
Eligibility
Age18 Years – 74 Years
Healthy vol.Accepted
Locations28 sites

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

Eligibility

Age: 18 Years – 74 YearsHealthy volunteers 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

Conditions2

DepressionMajor Depressive Disorder

Locations28 sites

Preferred Research Partner
Fayetteville, Arkansas, 72703
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Angelica Lau858-775-2053angelical@kadimanp.com
Psychedelic Science Institute
Santa Monica, California, 90404
Keith Heinzerling310-996-8966trialadmin@psychedelicsci.com
Mountain View Clinical Research, Inc
Denver, Colorado, 80209
Kristen Johnson720-941-9363Kristen@Mtnresearch.com

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