Treatment Resistant DepressionPhase 2P-TRDNCT03775200
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by COMPASS Pathways at 25 sites in 10 countries.
Trial summary
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 233 participants
- Where
- 25 sitesin 10 countries
- Study dates
- 1 Mar 2019to 27 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of TRD
Who cannot join
- Other comorbidities
Trial locations and contacts
25 sites in 10 countries.
25 sites in 10 countries
United States8 sites
Mood and Anxiety Disorders Program Emory University School of Medicine
Atlanta, Georgia, 30329
Sheppard Pratt Health System
Baltimore, Maryland, 21204
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
Houston, Texas, 77054
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Ray Worthy Psychiatry LLC
New Orleans, Louisiana, 70123
New York State Psychiatric Institute
New York, New York, 10032
Altman Clinical and Translational Research Institute, University of California
San Diego, California, 92093
Stanford Department of Psychiatry
Stanford, California, 94305
United Kingdom5 sites
Clinical Research and Imaging Centre
Bristol, Avon
St. Pancras Clinical Research
London, EC2Y 8EA
Kings College London, Institute of Psychiatry, Psychology and Neurology
London
Greater Manchester Mental Health Foundation Trust
Manchester
Wolfson Research Centre, Campus for Ageing and Vitality
Newcastle upon Tyne, Tyne and Wear, NE4 5PL
Netherlands3 sites
Groningen University Medical Centre
Groningen
Leiden University Medical Centre
Leiden
Utrecht University Medical Centre
Utrecht
Canada2 sites
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario
Spain2 sites
Hospital de Dia Numancia
Barcelona
Institute Hospital del Mar of Medical Research (IMIM)
Barcelona
Germany1 site
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
Berlin, 12203
Portugal1 site
Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
Lisbon
About this study
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
Read the detailed description
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
- Conditions
- Treatment Resistant Depression
- 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.
PsilocybinDrug
Dose-finding
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Low dose Psilocybin Receives: Drug: Psilocybin |
| Medium dose | Experimental | Medium dose Psilocybin Receives: Drug: Psilocybin |
| High dose | Experimental | High dose Psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score.
Measured: Change from Baseline to Week 3
MADRS Change From Baseline to Week 3, Sensitivity Analysis
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score.
Measured: Change from Baseline to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Mar 2019
- Primary completion30 Jul 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- COMPASS Pathways
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775200
- Sponsor's protocol ID
- COMP001
- Acronym
- P-TRD
- Status last verified
- Apr 2023
- First submitted
- 11 Dec 2018
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Goodwin GM, Aaronson ST, Alvarez O, Carhart-Harris R, Croal M, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Kirlic N, Licht RW, Marwood L, Nowakowska A, Palenicek T, Repantis D, Schoevers RA, Simmons H, Soares JC, Somers M, Tsai J, Wahba M, Williams E, Young AH, Young MB, Zisook S, Malievskaia E. The role of therapeutic alliance in psilocybin treatment for treatment-resistant depression: A post hoc path analysis. J Affect Disord. 2026 Aug 1;406:121662. doi: 10.1016/j.jad.2026.121662. Epub 2026 Mar 23.
PubMed 41881122Kirlic N, Atli M, Mistry S, Gold M, Goodwin GM. The Relationship Between Participant Pretreatment Clinical Presentation and the Quality of Psilocybin Experience: A Retrospective Analysis. J Clin Psychopharmacol. 2026 Mar-Apr 01;46(2):140-149. doi: 10.1097/JCP.0000000000002119. Epub 2025 Dec 9.
PubMed 41362124Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
PubMed 36322843Kelly JR, Baker A, Babiker M, Burke L, Brennan C, O'Keane V. The psychedelic renaissance: the next trip for psychiatry? Ir J Psychol Med. 2022 Dec;39(4):335-339. doi: 10.1017/ipm.2019.39. Epub 2019 Sep 23.
PubMed 31543078
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT03775200
- Acronym / sponsor ID
- P-TRD / COMP001
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- COMPASS PathwaysIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 24 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
Detailed description
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: PsilocybinLow dose Psilocybin |
| Medium dose | Experimental | Drug: PsilocybinMedium dose Psilocybin |
| High dose | Experimental | Drug: PsilocybinHigh dose Psilocybin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of TRD
Key exclusion criteria (1 listed)
- Other comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinDose-finding | Drug | High dose, Low dose, Medium dose |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
Time frame: Change from Baseline to Week 3
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score.
MADRS Change From Baseline to Week 3, Sensitivity Analysis
Time frame: Change from Baseline to Week 3
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41881122Goodwin GM, Aaronson ST, Alvarez O, Carhart-Harris R, Croal M, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Kirlic N, Licht RW, Marwood L, Nowakowska A, Palenicek T, Repantis D, Schoevers RA, Simmons H, Soares JC, Somers M, Tsai J, Wahba M, Williams E, Young AH, Young MB, Zisook S, Malievskaia E. The role of therapeutic alliance in psilocybin treatment for treatment-resistant depression: A post hoc path analysis. J Affect Disord. 2026 Aug 1;406:121662. doi: 10.1016/j.jad.2026.121662. Epub 2026 Mar 23.
- Derived from this study: PubMed 41362124Kirlic N, Atli M, Mistry S, Gold M, Goodwin GM. The Relationship Between Participant Pretreatment Clinical Presentation and the Quality of Psilocybin Experience: A Retrospective Analysis. J Clin Psychopharmacol. 2026 Mar-Apr 01;46(2):140-149. doi: 10.1097/JCP.0000000000002119. Epub 2025 Dec 9.
- Derived from this study: PubMed 36322843Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
- Derived from this study: PubMed 31543078Kelly JR, Baker A, Babiker M, Burke L, Brennan C, O'Keane V. The psychedelic renaissance: the next trip for psychiatry? Ir J Psychol Med. 2022 Dec;39(4):335-339. doi: 10.1017/ipm.2019.39. Epub 2019 Sep 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by COMPASS Pathways at 25 sites in 10 countries.
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 1 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: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, Netherlands, Canada, Spain and 5 more countries. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) Change From Baseline to Week 3 (time frame: Change from Baseline to Week 3). The study lists 2 primary outcomes in all. 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 NCT03775200, 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 24 Apr 2023.