A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

This Phase II, single-center trial (n=56) investigates the efficacy, safety, and tolerability of up to two doses of psilocybin (25mg) administered at an interval of 9 to 10 weeks in patients with Major Depressive Disorder (MDD) and cancer.

The study comprises a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and an open-label portion (Dosing Session 2). In Dosing Session 1, groups of two to four patients will be randomized to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session. The second session (Dosing Session 2) involves open-label administration of psilocybin 25 mg for eligible participants.

The study population includes adults (18 years and older) with MDD and a malignant neoplasm. The primary endpoint is the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 8. The trial is scheduled to start on July 7, 2023, and is estimated to complete by February 1, 2026. Renuka Surujnarain can be contacted for study-related information.

Trial Details

This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose. In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed. In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS < 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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 International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals. The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible.

Trial Number NCT05947383

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.