RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin for Major Depressive Disorder

This is an treatment, parallel arm assignment treatment study in individuals with Major Depressive Disorder (major depression). Each individual will be treated with a single dose of pimavanserin or dummy treatment (placebo) plus a single dose of psilocybin.

Official registry: https://clinicaltrials.gov/study/NCT06592833 · Icahn School of Medicine at Mount Sinai · enrollment listed as 60

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin, Pimavanserin, or Placebo. The registry lists allocation as randomized. This is an treatment, parallel arm assignment treatment study in individuals with Major Depressive Disorder (major depression).

They plan to enroll about 60 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients With Major Depressive Disorder

Interventions: Psilocybin, Pimavanserin, Placebo

Primary outcome (registry wording): Mystical Experience Questionnaire (MEQ-30) Score

Who it is for (from inclusion criteria)

Ages 21 Years to 80 Years
Age 21-80 years, any gender
Current primary diagnosis of Unipolar Major Depressive Disorder (major depression) without psychotic features using DSM-5 criteria
24-item Hamilton Rating Scale for Depression (HRSD) ≥16
Current diagnosis of Major Depressive Episode (MDE)
Discontinuation of any serotonergic drug for at least 2 weeks or 5 half-lives (whichever of the two is longer) prior to psilocybin exposure

Who the registry excludes

Any severity of substance use disorder in the last 6 months (excluding tobacco use disorder) as determined by DSM-V criteria via the SCID
Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months
Use of psychedelics in the last 12 months
Non-medical or illicit use of ketamine in the past 12 months
Negative reaction after prior use of psychedelics
Past or current psychotic disorder (including psychotic major depression), mania, or bipolar disorder
Severe depression as indicated by Clinical Global Impressions (CGI)-Severity score ≥ 5 at baseline

Public study contact (from the registry)

Depression and Anxiety Center Icahn School of Medicine at Mount Sinai

(212) 241-6539

dac@mssm.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT06592833 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06592833?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06592833?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary