A Multi-Center Randomized Double-Blind Support-of-Concept Phase 2 Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

Brief description of study

The purpose of this research is to study the medical and safety effects of a single dose of an investigational drug called psilocybin compared to an active placebo in participants with Major Depressive Disorder (MDD) who are otherwise medically healthy. When someone experiences persistent and intense feelings of sadness for extended periods of time, then they may have MDD. If you decide to participate in this study, you will undergo a psychological exam to determine if you have MDD. For purposes of this consent form, the term “depression” refers to MDD. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) for clinical use. However, we have permission from the FDA and the Drug Enforcement Agency (DEA) to use this drug in this research study. This is a randomized, double-blind, placebo-controlled research study. “Randomized” means you have an equal chance of getting either the psilocybin or active placebo and you do not get to choose which one you get. “Double-blind” means neither you nor the study team will know if you are taking psilocybin or the active placebo.

Clinical Study Identifier: s19-00006
ClinicalTrials.gov Identifier: NCT03866174

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