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ACTIVE NOT RECRUITING Phase 2

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

NCT04433858 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

Interventions

  • DRUG Psilocybin

Study Locations (2)

California

  • VA Palo Alto Healthcare System/Stanford Medicine — Palo Alto

Maryland

  • Sheppard Pratt Health System — Baltimore

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2021-03-01
Est. Completion 2026-05-01
Phase Phase 2

Sponsor

Sheppard Pratt Health System

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04433858

The ClinicalTrials.gov registry entry for NCT04433858 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sheppard Pratt Health System, which has 2 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 Treatment Resistant Depression appearing as the primary indexed condition, and to 1 intervention — of which Psilocybin 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: NCT04433858 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Maryland. 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 NCT04433858 about?

NCT04433858 is a clinical study titled "An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)". The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

What is the current status of trial NCT04433858?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2021-03-01. Estimated completion is 2026-05-01.

What conditions does trial NCT04433858 study?

This clinical trial studies the following conditions: Treatment Resistant Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04433858?

The interventions under investigation include: Psilocybin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04433858?

This trial is sponsored by Sheppard Pratt Health System, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04433858 being conducted?

This trial has 2 study locations across California, Maryland. 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