The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

  • End date
    Oct 26, 2023
  • participants needed
  • sponsor
    Maryland Oncology Hematology, PA
Updated on 20 October 2021


This is a Phase II, single-center, fixed dose, open label trial to explore the safety, tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD. The study population will include adult men and women, 18 years of age or above, with MDD, diagnosed with a malignant neoplasm. MDD is defined as those who meet DSM 5 diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the ICD-10.


Recent randomized, placebo-controlled clinical trials of psilocybin therapy for anxiety and depression associated with cancer diagnosis showed significant improvement in study endpoints reflecting psychological distress, as compared to placebo. The effects of a single psilocybin therapy session endured for up to six months with no specific follow-up care. In this study, we aim to explore the safety and efficacy of psilocybin therapy in cancer patients, diagnosed with Major Depressive Disorder (MDD).

Condition Major depression, Endogenous depression, major depressive disorder, major depressive disorders
Treatment Psilocybin
Clinical Study IdentifierNCT04593563
SponsorMaryland Oncology Hematology, PA
Last Modified on20 October 2021

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