PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.
- Status
- recruiting
- Phase
- Phase 1, Phase 2
- Institution
- Johns Hopkins University
- Principal investigator
- David B. Yaden, PhD
- Start date
- 2026-07-01
- End date
- 2028-12-01
- Registry ID
- NCT07610135
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.