Poster
58
(#58) Reduced Depressive Symptoms After a Single Treatment with MM120 (LSD) in Patients with Generalized Anxiety Disorder and Comorbid Depressive Symptoms
Psych Congress 2025
Abstract: Introduction: Generalized anxiety disorder (GAD) and major depressive disorder (MDD) are leading causes of disease burden. >50% of patients with GAD also have MDD, and effective and well-tolerated pharmacotherapies are needed for both disorders. A phase 2b study of a single treatment MM120 (lysergide D-tartrate; LSD) suggests a dose-dependent response in participants with moderate-to-severe GAD. In this post hoc analysis , MM120 treatment outcomes were explored in participants with high co-morbid depressive symptoms at baseline .
Methods: This phase 2b multicenter, randomized, double-blind, placebo-controlled study enrolled adults aged 18 to 74 years with moderate-to-severe GAD. Post hoc analyses examining MADRS change from baseline were performed in participants receiving 100µg MM120 and with a baseline MADRS>26
Results: Out of 198 participants enrolled, 115 of these had a baseline MADRS>26. Prespecified analysis of the 40 total participants who were received 100µg MM120, with a mean baseline MADRS of 26.5 ± 8.0, showed placebo-adjusted reductions in MADRS of 5.7 (P 0.05) and 6.4 (P≤0.05) and mean change from baseline scores of -18.1 ± 12.0 and -18.7 ± 11.5 at weeks 4 and 12.
Within the full safety set, treatment-emergent adverse events (TEAEs) occurred in 97.5% of participants in the MM120 100μg group versus 56.4% in the placebo group. Most events were mild to moderate, occurred on dosing day, and were consistent with the expected acute effects of MM120.
Conclusion: A single treatment of MM120 reduced depressive symptoms in participants with moderate to severe GAD. These analyses support the clinical development for MM120 in MDD.
Short Description: This post hoc analysis of a phase 2b study found that a single dose of MM120 (LSD) significantly reduced depressive symptoms in patients with moderate-to-severe GAD and high baseline depression (MADRS>26). Among participants receiving 100µg MM120, significant improvements in MADRS scores were observed at weeks 4 and 12. Most side effects were mild-to-moderate and occurred on dosing day. These findings support MM120's potential as a treatment for both GAD and MDD.
Name of Sponsoring Organization(s): Mind Medicine
Methods: This phase 2b multicenter, randomized, double-blind, placebo-controlled study enrolled adults aged 18 to 74 years with moderate-to-severe GAD. Post hoc analyses examining MADRS change from baseline were performed in participants receiving 100µg MM120 and with a baseline MADRS>26
Results: Out of 198 participants enrolled, 115 of these had a baseline MADRS>26. Prespecified analysis of the 40 total participants who were received 100µg MM120, with a mean baseline MADRS of 26.5 ± 8.0, showed placebo-adjusted reductions in MADRS of 5.7 (P 0.05) and 6.4 (P≤0.05) and mean change from baseline scores of -18.1 ± 12.0 and -18.7 ± 11.5 at weeks 4 and 12.
Within the full safety set, treatment-emergent adverse events (TEAEs) occurred in 97.5% of participants in the MM120 100μg group versus 56.4% in the placebo group. Most events were mild to moderate, occurred on dosing day, and were consistent with the expected acute effects of MM120.
Conclusion: A single treatment of MM120 reduced depressive symptoms in participants with moderate to severe GAD. These analyses support the clinical development for MM120 in MDD.
Short Description: This post hoc analysis of a phase 2b study found that a single dose of MM120 (LSD) significantly reduced depressive symptoms in patients with moderate-to-severe GAD and high baseline depression (MADRS>26). Among participants receiving 100µg MM120, significant improvements in MADRS scores were observed at weeks 4 and 12. Most side effects were mild-to-moderate and occurred on dosing day. These findings support MM120's potential as a treatment for both GAD and MDD.
Name of Sponsoring Organization(s): Mind Medicine
