drugset / Trial / NCT06592833

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

NCT06592833

Phase 2 Recruiting 60 enrolled Icahn School of Medicine at Mount Sinai
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-02-25
Primary completion
2028-03-01
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pimavanserin Small molecule 34 mg Oral
Comparator Psilocybin Other / unclassified 25 mg Oral