A Phase 2 Study to Evaluate the Efficacy and Safety of Psilocybin in Adults with MDD and Cancer

Major Depressive Disorder (MDD) is a chronic, recurring, and serious psychiatric disorder associated with high medical morbidity and diminished quality of life. The prevalence of MDD is higher in individuals with a cancer diagnosis, and there is currently no clear evidence that existing psychological interventions are efficacious in treating the distress associated with cancer.

Recent clinical trials, including one conducted at Sunstone Therapies, involving psilocybin for the treatment of anxiety and depression associated with cancer diagnoses showed significant improvements in psychological distress compared to placebo. This research is investigating the efficacy, safety, and tolerability of multiple psilocybin treatments, which has not yet been explored in this patient population.

This study aims to explore the efficacy, safety, and tolerability of psilocybin compared with an active placebo in cancer patients diagnosed with MDD. Secondarily, this study will investigate the efficacy of a second dose of psilocybin administered ~8 weeks after the first dosing session and assess whether a second dosing session improves remission rates and durability of outcomes.

This study involves the following in-person activities across an 18-20 week period:

• Two (2) screening visits
• Up to two (2) dosing sessions
• Nine (9) assessment visits
• Two (2) phone-call follow-up visits
• A variety of medical and psychiatric assessments are performed throughout the study, including blood draws.

• The study’s procedures and therapy are at no cost to the participant.
• Eligible participants will be randomized in a 1:1 ratio to receive 25mg of psilocybin or 100 mg of niacin (active placebo) during the first dosing session. No participants, research staff, nor therapists will know what drug the participant has received during their first session; this is otherwise known as a “blinded” study.
• Psilocybin will be administered in a safe setting with continual support from trained and experienced therapists. The support includes careful preparation before the experience and integration after the experience. Integration will be administered within a group structure. Psychedelic effects are typically temporary, and safety is continually monitored.

• Eligible participants will taper or discontinue all antidepressants as part of their participation in the study as applicable and with physician oversight. Participants MUST NOT discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
• Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
• Risks to participation will be reviewed extensively during the screening process and throughout the entirety of the trial.
• All visits take place in person at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.