Abstract
Objective: To evaluate the feasibility and prophylactic effect of psilocybin as well as its effects on hypothalamic functional connectivity (FC) in patients with chronic cluster headache (CCH). Background: CCH is an excruciating and difficult-to-treat disorder with incompletely understood pathophysiology, although hypothalamic dysfunction has been implicated. Psilocybin may have beneficial prophylactic effects, but clinical evidence is limited. Methods: In this small open-label clinical trial, 10 patients with CCH were included and maintained headache diaries for 10 weeks. Patients received three doses of peroral psilocybin (0.14 mg/kg) on the first day of weeks five, six, and seven. The first 4 weeks served as baseline and the last 4 weeks as follow-up. Hypothalamic FC was determined using functional magnetic resonance imaging the day before the first psilocybin dose and 1 week after the last dose. Results: The treatment was well tolerated. Attack frequency was reduced by mean (standard deviation) 31% (31) from baseline to follow-up (pFWER = 0.008). One patient experienced 21 weeks of complete remission. Changes in hypothalamic–diencephalic FC correlated negatively with a percent change in attack frequency (pFWER = 0.03, R = −0.81), implicating this neural pathway in treatment response. Conclusion: Our results indicate that psilocybin may have prophylactic potential and implicates the hypothalamus in possible treatment response. Further clinical studies are warranted.
Originalsprog | Engelsk |
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Tidsskrift | Headache |
Vol/bind | 64 |
Udgave nummer | 1 |
Sider (fra-til) | 55-67 |
ISSN | 0017-8748 |
DOI | |
Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:The study was sponsored by Augustinusfonden (grant number: 18‐0317), Rigshospitalet's Research Council (grant numbers: R130‐A5324 and R214‐A9447), Innovation Fund Denmark (NeuroPharm, grant number: 4108‐00004B), and Lundbeck Foundation through Danish Neurological Society.
Funding Information:
has received an honorarium as a speaker for Lundbeck Pharma and the Lundbeck Foundation. has received an honorarium as a speaker for the Lundbeck Foundation. has received honoraria as a consultant for Sanos and as a speaker for Sage‐Biogen. has given lectures for Pfizer, Eli Lilly, Merck, TEVA, Novartis, Lundbeck, and Allergan and is or has been primary investigator in clinical trials funded by Eli Lilly, Novartis, and Lundbeck. Rigmor H. Jensen has received research funding from the University of Copenhagen, Rigshospitalet, Lundbeck Foundation, The Medical Society in Copenhagen, NovoNordisk Foundation, and Tryg Foundation. and declare no conflicts of interest. Martin K. Madsen Dea S. Stenbæk Gitte M. Knudsen Rigmor H. Jensen Anja Sofie Petersen, Inger Marie Sørensen, Harald Schiønning, Tobias Fjeld, Charlotte H. Nykjær, Sara Marie Ulv Larsen, Maria Grzywacz, Tobias Mathiesen, Ida L. Klausen, Oliver Overgaard‐Hansen, Kristoffer Brendstrup‐Brix, Kristian Linnet, Sys S. Johansen, Patrick M. Fisher
Publisher Copyright:
© 2023 American Headache Society.