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

Summary

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.

Timeline

Start

2020-09-01

Primary completion

2022-10

Completion

2023-10

Publications

• Agrawal M, Richards W, Beaussant Y, Shnayder S, Ameli R, Roddy K, Stevens N, Richards B, Schor N, Honstein H, Jenkins B, Bates M, Thambi P. Psilocybin-assisted group therapy in patients with cancer diagnosed with a major depressive disorder. Cancer. 2024 Apr 1;130(7):1137-1146. doi: 10.1002/cncr.35010. Epub 2023 Dec 18.

Drugs

Indications