RECRUITING

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

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Conditions

Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2025-04-14
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06941844

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.

Ages Eligible for Study:18 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of MDD per DSM-5
  2. 2. Male or female aged 18 to 74
  3. 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
  4. 4. MADRS Total Score ≥26
  5. 5. CGI-S Score ≥4
  1. 1. Certain psychiatric disorders (other than major depressive disorder)
  2. 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
  3. 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
  4. 4. Any clinically significant unstable illness

Contacts and Locations

Study Contact

Mind Medicine, Inc.
CONTACT
1-332-282-0479
ClinicalTrials@Mindmed.co

Study Locations (Sites)

Preferred Research Partner
Fayetteville, Arkansas, 72703
United States
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211
United States
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
United States
Pacific Neuroscience Institute at Providence Saint John's
Santa Monica, California, 90404
United States
Mountain View Clinical Research, Inc
Denver, Colorado, 80209
United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
United States
Segal Trials- Center for Psychedelic Research
Lauderhill, Florida, 33319
United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
United States
Uptown Research
Chicago, Illinois, 60640
United States
Sheppard Pratt
Baltimore, Maryland, 21204
United States
Copley Clinical
Boston, Massachusetts, 02116
United States
Adams Clinical
Boston, Massachusetts, 02472
United States
University of Missouri
Columbia, Missouri, 65212
United States
Cenexel HRI
Berlin, New Jersey, 08053
United States
Berman Clinical
New York, New York, 10029
United States
Columbia - New York State Psychiatric Institute
New York, New York, 10032
United States
Neuro-Behavioral Clinical Research
Canton, Ohio, 44720
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119
United States
Dell Medical School, University of Texas at Austin
Austin, Texas, 78712
United States
Austin Clinical Trial Partners
Austin, Texas, 78737
United States
Cedar Clinical Research
Murray, Utah, 84020
United States
Memory Clinic, Inc
Bennington, Vermont, 05201
United States

Collaborators and Investigators

Sponsor: Mind Medicine, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-04-14
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder