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Treatment Resistant DepressionPhase 2NCT04433858

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

A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by Sheppard Pratt Health System at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Treatment Resistant Depression
What is being tested?
Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesUnited States
Study dates
1 Mar 2021to 1 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of at least moderate Major Depressive Disorder (MDD)

Who cannot join

  • Comorbidities
  • Note for CA site: Only Veterans are Eligible

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21204

  • VA Palo Alto Healthcare System/Stanford Medicine

    Palo Alto, California, 94304

Other trials in United States

About this study

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.

Being tested
Psilocybin
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04433858
Study groupRoleWhat they receive
PsilocybinExperimental25mg of Psilocybin Note: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery Asberg Depression Rating Scale (MADRS)

    MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score.

    Measured: From Baseline (Day -1) to three weeks post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start1 Mar 2021
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04433858
Sponsor's protocol ID
14947563
Status last verified
Aug 2024
First submitted
13 Jun 2020
Last updated
9 Aug 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kelly CM, Fradet M, Bostian CM, Donnelly A, Ellis S, Ostacher M, Aaronson S, Suppes T. Changes in anxiety, quality of life, and functioning following psilocybin-assisted therapy in veterans with treatment-resistant depression. J Affect Disord. 2026 Nov 1;412:122063. doi: 10.1016/j.jad.2026.122063. Epub 2026 Jun 4.

    PubMed 42248535

  • Ellis S, Bostian C, Donnelly A, Feng W, Eisen K, Lean M, Conlan E, Ostacher M, Aaronson S, Suppes T. Long-term outcomes of single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - 12-month data from an open-label pilot study. J Affect Disord. 2025 Nov 15;389:119655. doi: 10.1016/j.jad.2025.119655. Epub 2025 Jun 9.

    PubMed 40499827

  • Aaronson ST, van der Vaart A, Miller T, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Suppes T, Sackeim HA. Single-Dose Psilocybin for Depression With Severe Treatment Resistance: An Open-Label Trial. Am J Psychiatry. 2025 Jan 1;182(1):104-113. doi: 10.1176/appi.ajp.20231063.

    PubMed 39741440

  • Ellis S, Bostian C, Feng W, Fischer E, Schwartz G, Eisen K, Lean M, Conlan E, Ostacher M, Aaronson S, Suppes T. Single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - A first-in-kind open-label pilot study. J Affect Disord. 2025 Jan 15;369:381-389. doi: 10.1016/j.jad.2024.09.133. Epub 2024 Sep 27.

    PubMed 39343309

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by Sheppard Pratt Health System at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery Asberg Depression Rating Scale (MADRS) (time frame: From Baseline (Day -1) to three weeks post-dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433858, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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