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ACTIVE NOT RECRUITING Phase 3

Psilocybin for Major Depressive Disorder (MDD)

NCT06308653 · View on ClinicalTrials.gov ↗

Study Summary

Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period.

Conditions Studied

Interventions

  • DRUG Psilocybin 25 mg
  • DRUG Inactive Placebo
  • DRUG Psilocybin 5 mg
  • BEHAVIORAL Psychosocial Support

Study Locations (20)

California

  • Kadima Neuropsychiatry Institute — La Jolla
  • West LA VA Medical Center - Mental Health Department — Los Angeles
  • Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners — Santa Monica
  • Psychedelic Science Institute — Santa Monica

Florida

  • Clinical Neuroscience Solutions Inc. — Jacksonville
  • Innovative Clinical Research, Inc. — Lauderhill
  • Clinical Neuroscience Solutions, Inc. — Orlando

Arkansas

  • Preferred Research Partners-NWA, LLC — Fayetteville
  • Preferred Research Partners, Inc. — Little Rock

Georgia

  • Emory University — Atlanta
  • CenExel iResearch, LLC — Decatur

Maryland

  • Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research — Baltimore
  • Sunstone Medical PC — Rockville

Alabama

  • University of Alabama Clinical Research Unit — Birmingham

Colorado

  • Mountain View Clinical Research — Denver

Connecticut

  • Connecticut Mental Health Center, Yale University — New Haven

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2024-03-13
Est. Completion 2026-12-30
Phase Phase 3

Sponsor

Usona Institute

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06308653

The ClinicalTrials.gov registry entry for NCT06308653 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Usona Institute, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 4 interventions — of which Psilocybin 25 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06308653 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06308653 about?

NCT06308653 is a clinical study titled "Psilocybin for Major Depressive Disorder (MDD)". Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin ...

What is the current status of trial NCT06308653?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2024-03-13. Estimated completion is 2026-12-30.

What conditions does trial NCT06308653 study?

This clinical trial studies the following conditions: Depressive Disorder, Major. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06308653?

The interventions under investigation include: Psilocybin 25 mg (DRUG), Inactive Placebo (DRUG), Psilocybin 5 mg (DRUG), Psychosocial Support (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06308653?

This trial is sponsored by Usona Institute, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06308653 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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