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NCT07610135 · ClinicalTrials.gov registry record · Phase 1
Psilocybin Efficacy With or Without Pimavanserin Pretreatment
A Phase 1 study, sponsored by Johns Hopkins University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07610135: Clinical Trial Phase 1 study, sponsored by Johns Hopkins University.
NCT07610135 is a Phase 1 study that has not yet begun recruiting, run by Johns Hopkins University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07610135, a Phase 1 study, has not yet begun recruiting, sponsored by Johns Hopkins University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
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.
Interventions
- DRUG Psilocybin
- DRUG Pimavanserin
- DRUG Inactive Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07610135
The ClinicalTrials.gov registry entry for NCT07610135 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Psilocybin is the first listed.
NCT07610135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07610135 about?
NCT07610135 is a clinical study titled "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. ...
What is the current status of trial NCT07610135?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-07. Estimated completion is 2028-12.
What interventions are being tested in trial NCT07610135?
The interventions under investigation include: Psilocybin (DRUG), Pimavanserin (DRUG), Inactive Placebo (DRUG).
Who is sponsoring clinical trial NCT07610135?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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