A Case Series Providing Clinical Evidence that Methylone Produces Rapid and Robust Improvements in Major Depressive Disorder

Averill LA1,2,3,4*, Perelman M5, Ching THW3, Farré M6,7, Mandell B5, Stogniew M5, Seelig M8 and Kelmendi B3,4,5

1Department of Psychiatry and Behavioral Sciences, Division of Neuropsychiatry and Psychology, Baylor College of Medicine, USA
2Department of Veterans Affairs, Michael E. DeBakey VA Medical Center, USA
3Department of Psychiatry, Yale School of Medicine, USA
4Department of Veterans Affairs, National Center for PTSD – Division of Clinical Neurosciences, USA
5Transcend Therapeutics, New York, NY, USA
6Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol and Institut de Recerca Germans Trias i Pujol (HUGTiP-IGTP), Spain
7Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona (UAB), Spain
8Institute for Transpersonal Psychotherapy, USA

^*Correspondance to: Lynnette A Averill 

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Abstract:

Background: Methylone (3,4-methylenedioxy-N-methylcathinone; also known as MDMC, βk- MDMA, and M1), is a Rapid-Acting Entactogen (RAE) and phenethylamine compound with chemical and pharmacological properties similar to 3,4-Methylenedioxymethamphetamine (MDMA). A study comparing the acute effects of methylone and MDMA in healthy participants reported that while the subjective pharmacological effects of the two drugs were categorically similar, methylone demonstrated significant clinical, physiological, and pharmacological differences, including “softer” empathogenic and psychostimulant effects that may have potential for accelerated adoption across a broad range of medical settings and clinical applications. A recently published case series reported on methylone’s potential as a treatment for stress- and trauma-related concerns, describing outcomes from 21 complex patients with PTSD as a primary diagnosis. Objective: Here, we present a case series of clinical data from 7 patients (4 female, mean age = 42 years) treated with oral methylone for MDD in a naturalistic setting. Methods: Archival data were used to examine patient characteristics and outcomes. Results: Methylone was well tolerated. All patients achieved “very much improved” (n=3) or “much improved” (n=3) ratings on the Clinician Global Impressions-Improvement (CGI-I) scale. Conclusion: Methylone appears to produce rapid, robust, and durable clinical benefits. There is an urgent need for rapid-acting, and robust interventions for MDD, especially for those patients not gaining clinical benefit from available treatments, such as SSRIs, and that can address some of the limitations and barriers to other rapid-acting interventions. These promising findings warrant further study to characterize the role and safety of methylone as a potential pharmacotherapy for MDD and other stress-related concerns.

Keywords:

Major depressive disorder; Methylone; Treatment; Case series; Rapid Acting Entactogen

Cite the Article:

Averill LA, Perelman M, Ching THW, Farré M, Mandell B, Stogniew M, et al. A Case Series Providing Clinical Evidence that Methylone Produces Rapid and Robust Improvements in Major Depressive Disorder. Ann Clin Case Rep. 2023; 8: 2519.