drugset / Trial / NCT03356483
Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.
Phase 1
Completed
31 enrolled
Yale University
Heffter Research Institute · collabNational Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate psilocybin's purported therapeutic effects on OCD.
Timeline
- Start
- 2018-11-13
- Primary completion
- 2024-07-25
- Completion
- 2024-07-25
Publications
- Background Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006 Nov;67(11):1735-40. doi: 10.4088/jcp.v67n1110.
- Background Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z, Corby P, Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016 Dec;30(12):1165-1180. doi: 10.1177/0269881116675512.
- Background Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
- Background Carhart-Harris RL, Erritzoe D, Williams T, Stone JM, Reed LJ, Colasanti A, Tyacke RJ, Leech R, Malizia AL, Murphy K, Hobden P, Evans J, Feilding A, Wise RG, Nutt DJ. Neural correlates of the psychedelic state as determined by fMRI studies with psilocybin. Proc Natl Acad Sci U S A. 2012 Feb 7;109(6):2138-43. doi: 10.1073/pnas.1119598109. Epub 2012 Jan 23.
- Ching THW, Grazioplene R, Bohner C, Kichuk SA, DePalmer G, D'Amico E, Eilbott J, Jankovsky A, Burke M, Hokanson J, Martins B, Witherow C, Patel P, Amoroso L, Schaer H, Pittenger C, Kelmendi B. Safety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive-compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial. Front Psychiatry. 2023 Apr 25;14:1178529. doi: 10.3389/fpsyt.2023.1178529. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 0.25 mg/kg | Oral |