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The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | Low dose Psilocybin |
|
| Medium dose | Experimental | Medium dose Psilocybin |
|
| High dose | Experimental | High dose Psilocybin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Dose-finding |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change from Baseline to Week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | United States | ||
| Altman Clinical and Translational Research Institute, University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41881122 | Derived | 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. | |
| 41362124 |
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First patient first visit: 1 March 2019 Last patients last visit: 27 September 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 mg COMP360 Psilocybin | 25 mg COMP360 Psilocybin |
| FG001 | 10 mg COMP360 Psilocybin | 10 mg COMP360 Psilocybin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2019 | Jan 31, 2023 |
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| San Diego |
| California |
| 92093 |
| United States |
| Stanford Department of Psychiatry | Stanford | California | 94305 | United States |
| Mood and Anxiety Disorders Program Emory University School of Medicine | Atlanta | Georgia | 30329 | United States |
| Ray Worthy Psychiatry LLC | New Orleans | Louisiana | 70123 | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | United States |
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| UT Center of Excellence on Mood Disorders, University of Texas Health Science Center | Houston | Texas | 77054 | United States |
| Canadian Rapid Treatment Centre of Excellence | Mississauga | Ontario | Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | Canada |
| National Institute of Mental Health Czech Republic | Klecany | Czechia |
| Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg | Aalborg | Denmark |
| Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Tallaght University Hospital | Dublin | Ireland |
| Groningen University Medical Centre | Groningen | Netherlands |
| Leiden University Medical Centre | Leiden | Netherlands |
| Utrecht University Medical Centre | Utrecht | Netherlands |
| Unidade de Neuropsiquiatria, Centro Clinico Champalimaud | Lisbon | Portugal |
| Hospital de Dia Numancia | Barcelona | Spain |
| Institute Hospital del Mar of Medical Research (IMIM) | Barcelona | Spain |
| Clinical Research and Imaging Centre | Bristol | Avon | United Kingdom |
| Wolfson Research Centre, Campus for Ageing and Vitality | Newcastle upon Tyne | Tyne and Wear | NE4 5PL | United Kingdom |
| St. Pancras Clinical Research | London | EC2Y 8EA | United Kingdom |
| Kings College London, Institute of Psychiatry, Psychology and Neurology | London | United Kingdom |
| Greater Manchester Mental Health Foundation Trust | Manchester | United Kingdom |
| Derived |
| Kirlic 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. |
| 36322843 | Derived | Goodwin 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. |
| 31543078 | Derived | Kelly 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. |
| FG002 |
| 1 mg COMP360 Psilocybin |
1 mg COMP360 Psilocybin |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all randomised participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 25 mg COMP360 Psilocybin | 25 mg COMP360 Psilocybin |
| BG001 | 10 mg COMP360 Psilocybin | 10 mg COMP360 Psilocybin |
| BG002 | 1 mg COMP360 Psilocybin | 1 mg COMP360 Psilocybin |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Age at Screening | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set includes all participants randomised who receive study drug and have at least 1 post-dose efficacy assessment. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Week 3 |
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| Primary | 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. | The per-protocol analysis set includes all participants in the Full Analysis Set who do not have a protocol deviation that is thought to significantly affect the integrity of the participant's efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Week 3 |
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Up to 12 Weeks
The Safety Analysis Set included all randomised participants who received study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25 mg COMP360 Psilocybin | 25 mg COMP360 Psilocybin | 0 | 79 | 5 | 79 | 60 | 79 |
| EG001 | 10 mg COMP360 Psilocybin | 10 mg COMP360 Psilocybin | 0 | 75 | 6 | 75 | 51 | 75 |
| EG002 | 1 mg COMP360 Psilocybin | 1 mg COMP360 Psilocybin | 0 | 79 | 1 | 79 | 50 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug withdrawal syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Adjustment disorder with anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Panic reaction | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Thinking abnormal | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Compass Pathways | 07443136539 | info@compasspathways.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2021 | Feb 7, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Netherlands |
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| United States |
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| Czechia |
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| Ireland |
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| Denmark |
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| United Kingdom |
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| Portugal |
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| Germany |
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| Spain |
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| Other |
For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0. |
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