drugset / Trial / NCT05546658
Effects of Psilocybin in Obsessive Compulsive Disorder
RandomizedCrossoverOpen-labelTreatment
Summary
This study will test the feasibility, safety, and evidence for efficacy of psilocybin administration in participants with obsessive compulsive disorder (OCD). This will serve as a preliminary proof of concept study for future larger studies aimed to investigate the utility, cognitive mechanisms, and neural correlates of this intervention.
Timeline
- Start
- 2022-11-28
- Primary completion
- 2026-09-12
- Completion
- 2027-09-12
Publications
- Background Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
- Background Spilberger, C. (1983). Manual for the state-trait anxiety inventory: STAI (Form Y). Palo Alto.
- Background Beck, A.T., Steer, R.A. and Brown, G.K. (1996) Beck Depression Inventory-II. San Antonio, 78, 490-498.
- Background Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
- Background Doss MK, Weafer J, Gallo DA, de Wit H. Delta9-Tetrahydrocannabinol at Retrieval Drives False Recollection of Neutral and Emotional Memories. Biol Psychiatry. 2018 Nov 15;84(10):743-750. doi: 10.1016/j.biopsych.2018.04.020. Epub 2018 May 9.
- Background Doss MK, Weafer J, Gallo DA, de Wit H. MDMA Impairs Both the Encoding and Retrieval of Emotional Recollections. Neuropsychopharmacology. 2018 Mar;43(4):791-800. doi: 10.1038/npp.2017.171. Epub 2017 Aug 21.
- Background Banca P, Vestergaard MD, Rankov V, Baek K, Mitchell S, Lapa T, Castelo-Branco M, Voon V. Evidence accumulation in obsessive-compulsive disorder: the role of uncertainty and monetary reward on perceptual decision-making thresholds. Neuropsychopharmacology. 2015 Mar 13;40(5):1192-202. doi: 10.1038/npp.2014.303.
- Background Marton T, Samuels J, Nestadt P, Krasnow J, Wang Y, Shuler M, Kamath V, Chib VS, Bakker A, Nestadt G. Validating a dimension of doubt in decision-making: A proposed endophenotype for obsessive-compulsive disorder. PLoS One. 2019 Jun 13;14(6):e0218182. doi: 10.1371/journal.pone.0218182. eCollection 2019.
- Background Daw ND, Gershman SJ, Seymour B, Dayan P, Dolan RJ. Model-based influences on humans' choices and striatal prediction errors. Neuron. 2011 Mar 24;69(6):1204-15. doi: 10.1016/j.neuron.2011.02.027.
- Background Gillan CM, Kalanthroff E, Evans M, Weingarden HM, Jacoby RJ, Gershkovich M, Snorrason I, Campeas R, Cervoni C, Crimarco NC, Sokol Y, Garnaat SL, McLaughlin NCR, Phelps EA, Pinto A, Boisseau CL, Wilhelm S, Daw ND, Simpson HB. Comparison of the Association Between Goal-Directed Planning and Self-reported Compulsivity vs Obsessive-Compulsive Disorder Diagnosis. JAMA Psychiatry. 2020 Jan 1;77(1):77-85. doi: 10.1001/jamapsychiatry.2019.2998.
- Background Grundler TO, Cavanagh JF, Figueroa CM, Frank MJ, Allen JJ. Task-related dissociation in ERN amplitude as a function of obsessive-compulsive symptoms. Neuropsychologia. 2009 Jul;47(8-9):1978-87. doi: 10.1016/j.neuropsychologia.2009.03.010. Epub 2009 Mar 17.
- Background Riesel A, Goldhahn S, Kathmann N. Hyperactive performance monitoring as a transdiagnostic marker: Results from health anxiety in comparison to obsessive-compulsive disorder. Neuropsychologia. 2017 Feb;96:1-8. doi: 10.1016/j.neuropsychologia.2016.12.029. Epub 2016 Dec 29.
- Background John, O. P., Naumann, L. P., & Soto, C. J. (2008). Paradigm shift to the integrative Big Five trait taxonomy: History, measurement, and conceptual issues. Handbook of Personality: Theory and Research, 3rd Ed., 114.
- Background Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background Guy, W. (1976). ECDEU assessment manual for psychopharmacology-revised (DHEW publ no ADM 76-338). rockville, MD, US department of health, education, and welfare. Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs, 1076, 534-537.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 30 mg | — |