TL;DR
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A small, open-label trial found that a blood-based inflammation index was lower at follow-up after psilocybin therapy in people with Parkinson’s disease and mood dysfunction. Some mitochondrial stress marker changes did not persist, and the researchers say the findings need testing in larger randomized trials.
A small, nonrandomized trial found that an index of systemic inflammation was lower after psilocybin therapy in people with Parkinson’s disease and mood dysfunction, with the reduction still evident 30 days after the higher dose. The results, reported by University of California, San Francisco researchers, are biological findings—not evidence that psilocybin treats Parkinson’s disease—and require confirmation in larger randomized trials.
The open-label study included 12 people ages 40 to 75 with mild-to-moderate Parkinson’s disease. Participants received oral synthetic psilocybin at doses of 10 milligrams and 25 milligrams, administered about two weeks apart. Researchers collected and analyzed plasma samples from nine participants at baseline, one day after each dose, and 30 days after the 25-milligram dose.
The primary inflammation measure combined levels of IL-6, IL-8, tumor necrosis factor alpha, interferon gamma and high-sensitivity C-reactive protein into a proinflammatory index. Compared with baseline, the index was lower one day after 10 milligrams (standardized mean difference, or SMD, of -0.72; adjusted P=0.003), one day after 25 milligrams (SMD -0.60; adjusted P=0.02), and 30 days after 25 milligrams (SMD -0.62; adjusted P=0.047), the researchers reported in a JAMA Psychiatry research letter.
Individual markers did not all show the same pattern. IL-6 was significantly lower and IL-10 higher one day after the 10-milligram dose, but neither difference was reported at later time points. The team also measured mitochondrial stress using GDF-15 and FGF-21. GDF-15 was lower one day after each dose but was no longer lower than baseline at day 30; FGF-21 rose after each dose, though the increase was not statistically significant.
What the Biomarker Changes Show
The findings add early data on possible biological effects of psychedelic therapy in a neurodegenerative condition. Most research on psilocybin and related drugs has focused on mental health conditions, according to Albert Garcia-Romeu, a Johns Hopkins University School of Medicine researcher who was not involved in the trial. He said the study offers evidence that psilocybin may affect inflammation and mitochondrial stress markers in people with Parkinson’s.
The results do not establish that the marker changes caused improvements in symptoms, or that they will occur in a broader group of patients. The study’s parent trial had reported an association between psilocybin therapy and reduced depression, anxiety and motor symptoms, but this biomarker analysis does not show that reduced inflammation explains those clinical findings. Researchers say further work is needed to test whether the biological changes are reproducible and whether they relate to patient outcomes.
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From Mood Symptoms to Biology
The biomarker analysis was conducted within research on psilocybin therapy for people with Parkinson’s who also had mood dysfunction. In the parent trial, the therapy was associated with changes in depression, anxiety and motor symptoms. The new report examines blood markers, rather than establishing a new treatment effect on those symptoms or on the underlying progression of Parkinson’s disease.
Lead author Ellen Bradley of UCSF told MedPage Today that the report is, to the researchers’ knowledge, the first to describe changes in these types of markers after psychedelic treatment in people with a neurodegenerative disease. Garcia-Romeu described the work as part of broader research into potential biological effects of psychedelics beyond psychiatric conditions. Both points reflect the study’s early, exploratory status.
“To our knowledge, this is the first report of changes in these types of markers after psychedelic treatment in people with a neurodegenerative disease.”
— Ellen Bradley, MD, University of California, San Francisco
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Limits of the Early Findings
The study was small and nonrandomized, and blood samples were available from only nine of the 12 participants. Without a control group, the analysis cannot determine whether psilocybin caused the observed changes or rule out other explanations. The report also does not establish whether changes in the markers correspond to meaningful or lasting benefits for patients.
The inflammation index remained lower at the reported 30-day measurement, but the follow-up period was limited. GDF-15’s reduction was not present at that later measurement, and the FGF-21 increase was not statistically significant. It remains unclear whether the findings will hold in a larger population, how long any changes might last, or whether they are related to clinical outcomes.
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Randomized Parkinson’s Trial Under Way
O’Donovan told MedPage Today that the UCSF team is following up with more detailed analyses of inflammation and mitochondrial stress in a randomized controlled trial involving people with Parkinson’s disease. That work may help test whether the signals in this small open-label study are reproducible under a stronger study design. The source report did not provide a completion date or results timeline for the Parkinson’s trial.
Separately, Garcia-Romeu said his group was studying psilocybin in people with mild cognitive impairment or early-stage Alzheimer’s disease and depression. At the time of his comments, 18 participants had been treated and 19 of a planned 20 had enrolled; he said the team planned to finish the trial and publish findings the following year. That study is separate from the Parkinson’s research and does not confirm its results.
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Key Questions
What did the Parkinson’s trial find?
Researchers reported that a combined inflammation index was lower at each measured follow-up after psilocybin compared with baseline, including 30 days after the 25-milligram dose. The trial was small and did not establish that psilocybin caused the changes.
Did the study show that psilocybin treats Parkinson’s disease?
No. This report measured blood-based inflammation and mitochondrial stress markers. It does not establish psilocybin as a treatment for Parkinson’s disease or show that changes in those markers improve symptoms or alter disease progression.
How many people took part?
The open-label trial enrolled 12 people with mild-to-moderate Parkinson’s disease and mood dysfunction. Plasma samples were analyzed for nine participants.
What happens next?
UCSF researchers are conducting a randomized controlled trial to examine psilocybin’s effects on inflammation and mitochondrial stress in people with Parkinson’s. The report did not give a timeline for results.
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