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
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Sponsors & Collaborators
MindMedMindMed is one of the largest companies in the psychedelics space and is developing various psychedelics for mental health disorders.