RECRUITING

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

Description

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

Study Overview

Study Details

Study overview

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

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

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Fayetteville

Preferred Research Partner, Fayetteville, Arkansas, United States, 72703

Little Rock

Preferred Research Partners, Inc, Little Rock, Arkansas, United States, 72211

La Jolla

Kadima Neuropsychiatry Institute, La Jolla, California, United States, 92037

Santa Monica

Pacific Neuroscience Institute at Providence Saint John's, Santa Monica, California, United States, 90404

Denver

Mountain View Clinical Research, Inc, Denver, Colorado, United States, 80209

Jacksonville

Clinical Neuroscience Solutions, Inc, Jacksonville, Florida, United States, 32256

Lauderhill

Segal Trials- Center for Psychedelic Research, Lauderhill, Florida, United States, 33319

Orlando

Clinical Neuroscience Solutions, Inc, Orlando, Florida, United States, 32801

Chicago

Uptown Research, Chicago, Illinois, United States, 60640

Baltimore

Sheppard Pratt, Baltimore, Maryland, United States, 21204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 74 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mind Medicine, Inc.,

Study Record Dates

2027-05