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NOT YET RECRUITING
NCT07610135
PHASE1/PHASE2

Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

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.

Official title: PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06

Completion Date

2028-12

Last Updated

2026-05-27

Healthy Volunteers

Yes

Interventions

DRUG

Psilocybin

Psilocybin, 25 mg, oral, single dose

DRUG

Pimavanserin

Pimavanserin, 34 mg, oral, two doses

DRUG

Inactive Placebo

Inactive placebo, oral, two doses

Locations (1)

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States