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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Major Depressivie Disorder
  • Age: Between 21 - 65 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects are able to read, speak, and understand English
    2. Subjects are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations
    3. Subjects are able to swallow capsules
    4. Meet DSM-5 criteria for a diagnosis of major depressive disorder
    5. Have sustained moderate-severe depression symptoms
    6. Central rater MADRS and computer administered MADRS total scores show = 7 point difference between scores at both Screening and Baseline
    7. Have an identified support person who drives home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing

You may not be eligible for this study if the following are true:

    1. Subjects who are pregnant or breastfeeding
    2. Subjects unwilling or unable to discontinue formal psychotherapy
    3. Subjects unwilling to discontinue any current prescription or supplemental psychotropic agents
    4. Have previously received the following non-medication treatments of deep brain stimulation(DBS) or vagus nerve stimulation (VNS)
    5. Subjects currently receiving electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
    6. Unable or unwilling to discontinue any current medications having a primary centrally-acting serotonergic effect
    7. Unable or unwilling to discontinue any current medications that are known uridine diphosphate (UDP) or glucuronosyltransferase (UGT) enzyme modulators
    8. Subjects using psychedelic substances
    9. Subjects with cardiovascular conditions
    10. Subjects with elevated blood pressure
    11. Meet DSM-5 criteria for schizophrenia spectrumli>
    12. Meet DSM-5 criteria for antisocial personality disorder
    13. Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.