Psilocybin for Depression in Adults with Cancer
This study is looking at whether two doses of psilocybin (25 mg oral capsule) can help adults with cancer who also have Major Depressive Disorder (MDD). Participants will receive either psilocybin or a placebo (niacin 100 mg oral capsule) in the first part of the study. If their depression symptoms don't improve, they may receive psilocybin in a second part. The study aims to see how well psilocybin works, if it's safe, and if people can tolerate it. We'll measure success by checking changes in depression symptoms using a scale called the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks. This study plans to enroll 56 participants and is currently unclear on its recruitment status. You can join if you are 18 or older and meet the criteria for MDD.
- Study design
- This is a Phase 2, single-center study. It is double-blinded (meaning neither you nor your doctors will know if you're getting psilocybin or placebo at first), randomized, and placebo-controlled, with a total of 56 planned participants.
- What's involved
- You would participate in two dosing sessions, spaced 9 to 10 weeks apart. Each session involves receiving a capsule and being supported by a therapist.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your depression symptoms will be measured at 8 weeks after the first dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- The Montgomery-Asberg Depression Rating Scale (MADRS)8 weeks
The primary endpoint of efficacy (psilocybin versus active placebo) in this study will be evaluated as change from baseline in MADRS total score at V7 (Week 8).