The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Summary

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Timeline

Start

2019-03-01

Primary completion

2021-07-30

Completion

2021-09-27

Outcome

Met primary endpoint

registry 25 mg COMP360 Psilocybin vs 1 mg COMP360 Psilocybin; p <0.05; Least Mean Square Difference -6.6 (95% CI -10.2 to -2.9) NCT03775200 ↗

registry 25 mg COMP360 Psilocybin vs 1 mg COMP360 Psilocybin; p <0.05; Least Mean Square Difference -5.6 (95% CI -9.4 to -1.8) NCT03775200 ↗

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.
• 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Psilocybin	Other / unclassified	1 mg	—
Subject	Psilocybin	Other / unclassified	10 mg	—
Subject	Psilocybin	Other / unclassified	25 mg	—

Indications

No indication recorded.