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

This randomised, double-blind, placebo-controlled Phase III trial (n=140) will evaluate the efficacy and safety of a single oral dose of MM120 (100 µg LSD D-tartrate) for the treatment of major depressive disorder (MDD).

Conducted by MindMed (Mind Medicine, Inc.), this study will enrol adults aged 18 to 74 who are currently experiencing a moderate to severe depressive episode. Participants must meet diagnostic criteria for MDD and reach a minimum threshold on standardised depression severity scales.

The study includes a 12-week double-blind treatment phase comparing MM120 with placebo, followed by a 40-week open-label extension in which participants may receive additional MM120 doses if needed, based on symptom severity and pre-specified safety criteria. Secondary outcome measures will assess a wide range of clinical and quality-of-life domains, including depression response and remission rates, anxiety, global functioning, sexual health, work productivity, and overall wellbeing, during both the double-blind and open-label periods. This trial aims to determine whether a single dose of MM120 can offer sustained relief from depressive symptoms and improve broader aspects of daily functioning in people with MDD.

Trial Details

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.

Trial Number NCT06941844

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.