NCT04519957 is a clinical trial in Treatment Resistant Depression, sponsored by COMPASS Pathways.

Who is sponsoring NCT04519957?

NCT04519957 is sponsored by COMPASS Pathways.

What condition does NCT04519957 study?

NCT04519957 studies Treatment Resistant Depression.

Is NCT04519957 still recruiting?

NCT04519957 is currently completed. Last updated 22 September 2022.

Last reviewed 2022-09-22 · How we verify

NCT04519957

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)

Completed Last updated 22 September 2022

What this trial tests

trial in Treatment Resistant Depression in 66 participants. Completed in 11 August 2022.

Timeline

20 July 2020

Primary endpoint
11 August 2022

11 August 2022

Quick facts

Lead sponsor	COMPASS Pathways
Status	Completed
Study type	OBSERVATIONAL
Enrollment	66
Start date	20 July 2020
Primary completion	11 August 2022
Estimated completion	11 August 2022
Sites	8 locations across Netherlands, Ireland, United Kingdom, United States, Czechia

Conditions studied

Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

COMPASS Pathways — full company profile →

Who can join

Adults 18 to 55, any sex, with Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges.
Lucido MJ, Dunlop BW. · · 2025 · cited 7× · PMID 40002494 · DOI 10.3390/brainsci15020161
Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder.
Goodwin GM, Nowakowska A, Atli M, Dunlop BW, et al · · 2025 · cited 4× · PMID 40047545 · DOI 10.4088/jcp.24m15449
A review of psychedelics trials completed in depression, informed by European regulatory perspectives.
Silva F, Butlen-Ducuing F, Guizzaro L, Balabanov P. · · 2025 · PMID 40654583 · DOI 10.1016/j.nsa.2025.105516

Verify or expand the search:

Other recruiting trials for Treatment Resistant Depression

Currently open trials in the same condition.

NCT07183748 — Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression · Phase 2 · recruiting
NCT06938841 — Maintenance rTMS for Depression (Maitr-De) · NA · recruiting
NCT06236711 — Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) · NA · active not recruiting
NCT05774665 — Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression · Phase 2 · active not recruiting
NCT06895863 — COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression · NA · recruiting

Other COMPASS Pathways trials

Trials by the same sponsor.

NCT05481736 — Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study · Phase 2 · completed
NCT05312151 — The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder · Phase 2 · completed
NCT04739865 — The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression · Phase 2 · completed
NCT03775200 — The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04519957 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by COMPASS Pathways
Last refreshed: 22 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04519957.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing