drugset / Trial / NCT06592833
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pimavanserin | Small molecule | 34 mg | Oral |
| Comparator | Psilocybin | Other / unclassified | 25 mg | Oral |