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.

Topic Treatment-Resistant Depression Depression
Compound Psilocybin Placebo
Country United States of America
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Sunstone Therapies
Sunstone Therapies is dedicated to the development and implementation of innovative therapies for individuals affected by cancer and other conditions.

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