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The pharmacological treatment of depression consists of taking antidepressant drugs for prolonged periods; its modest therapeutic effect can often be associated with significant adverse effects, while its discontinuation can lead to relapses. Psilocybin is today a novel and breakthrough therapy for major depression. It is a natural alkaloid in  Psilocybe  mushrooms, which are endemic to Mexico. Research on a larger scale is lacking in various populations, including the Mexican people. This proposal contemplates the experimental design of a preclinical (toxicity and pharmacological evaluation of an extract in mice) and clinical study by including the chemical analysis of a species of  Psilocybe cubensis  mushroom to characterize its main constituents. The clinical study will consider the safety evaluation by exploring tolerated doses of  Psilocybe cubensis  by measuring pharmacokinetic parameters after oral administration in healthy adults and an open trial on a sample of patients with major depressive disorder to assess the safety and efficacy of fully characterized  Psilocybe cubensis  in a two-single doses treatment, (with assisted psychotherapy), compared with the traditional care model at the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz in Mexico City. This report presents the design of a research project with preclinical and clinical experimental components.

journal of psychoactive drugs

A Proposal to Study the Safety and Efficacy of  Psilocybe cubensis  in Preclinical and Clinical Studies as a Therapeutic Alternative for Major Depressive Disorder