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Psilocybin Efficacy With or Without Pimavanserin Pretreatment

NCT07610135 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

  • Mood (Psychological Function)
  • Well Being
  • Mood
  • Healthy

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

Sponsors & Collaborators

Principal Investigators

  • David B. Yaden, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610135 on ClinicalTrials.gov