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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). 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.
Primary Outcome
Persisting effects will be assessed using the single item well-being item from the Persisting Effects Questionnaire (PEQ) at 1-week (primary inferential contrast) and 1-month post-dosing. The PEQ is an instrument designed to measure participants' retrospective attributions regarding the longer-term impact of the psilocybin experience, including effects on mood, behavior, and overall well-being. The item is rated on a 7-point Likert scale (-3 = decreased very much; -2 = decreased moderately; -1 =
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 |
What is known before NCT07610135 opens enrollment
NCT07610135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Psilocybin is the first listed.
NCT07610135 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07610135's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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