Clinical Trials

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

Study Status: Recruiting

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.

  • Sex: ALL
  • Minimum Age: 18 Years
  • Maximum Age: 74 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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

Exlusion 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

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Major Depressive Disorder

Intervention/Treatment

Intervention/Treatment

  • OTHER : Placebo
  • DRUG : MM120 (LSD D-Tartrate)

Sponsor

Mind Medicine, Inc.

Phase

  • PHASE3