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NCT06592833 · ClinicalTrials.gov registry record · Phase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
A Phase 2 study of Major Depressive Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06592833: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06592833 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 60 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06592833, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing.
Primary Outcome
Acute subjective effects of psilocybin measured by the Mystical Experience Questionnaire (MEQ-30). Full Scale ranges from 0 to 150, with higher scores indicating more mystical experience.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Psilocybin
- DRUG Pimavanserin
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What NCT06592833 shows while recruiting
NCT06592833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06592833 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06592833 about?
NCT06592833 is a clinical study titled "Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder". This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at seve...
What is the current status of trial NCT06592833?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-02-25. Estimated completion is 2028-03-01.
What conditions does trial NCT06592833 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06592833?
The interventions under investigation include: Placebo (DRUG), Psilocybin (DRUG), Pimavanserin (DRUG).
Who is sponsoring clinical trial NCT06592833?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06592833 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06592833's enrollment target sits among peer trials
60 168th of 282 higher than 111 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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