Psilocybin-Assisted Therapy in Treatment-Resistant Depression
Trial Parameters
Brief Summary
The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of screening and preparation visits. * Be given psilocybin in one or two treatment sessions. * Attend a series of follow-up sessions over the following year. * Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.
Eligibility Criteria
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 potentia