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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 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.

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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.

Conditions Studied

Major Depressive Disorder

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

FieldValue
Enrollment Target 60 participants
Start Date 2025-02-25
Est. Completion 2028-03-01
Phase Phase 2

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06592833

The ClinicalTrials.gov registry entry for NCT06592833 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.