Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder

This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing.

NCT Number	NCT06592833
Lead Sponsor	Icahn School of Medicine at Mount Sinai
Conditions	Major Depressive Disorder
Enrollment	60 participants
Start Date	2025-02-25
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-03-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-14