Psilocybin-Assisted Therapy in Treatment-Resistant Depression

Inclusion Criteria: * Provision of signed and dated informed consent form. * Willingness to comply with all study procedures and availability for the study. * Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) diagnosis of major depressive disorder. * Currently experiencing a major depressive episode, lasting at least 3 months * Failure to respond or inability to tolerate at least 2 guideline-concordant pharmacological treatments from different pharmacologic classes during the current major depressive episode * Good health evidenced by medical history and routine lab tests * No central nervous system (CNS) or neurocognitive impairment * Ability to take oral medication and to follow to the psilocybin-assisted therapy protocol * Identified support person to accompany patient home after dosing * Use of effective contraception throughout the study by those with child-bearing potential * Use of condoms or other effective contraceptive methods by males with reproductive potential * Fully vaccinated and up to date on vaccination against COVID-19, as defined by Center for Disease Control guidelines * Following Lifestyle Considerations throughout study (no nicotine containing products in clinical unit, refrain from operating heavy machinery for the duration of treatment day, no more than two servings 8 hours prior to treatment, no psychoactive drugs 72 hours before treatment, refrain from consuming foods that would interfere with drug absorption, minimize interaction wit…