Clinical Trials

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

Study Status: Active Not 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

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

Conditions

Major Depressive Disorder

Intervention/Treatment

Intervention/Treatment

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

Sponsor

Definium Therapeutics US, Inc.

Phase

  • PHASE3