TL;DR
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A small, open-label trial found that a blood-based inflammation index was lower than baseline at follow-up after psilocybin therapy in people with Parkinson’s disease and mood dysfunction. Some mitochondrial stress marker changes were short-lived; the study cannot establish that psilocybin caused the changes or that they improved patients’ health.
A small, nonrandomized trial found that an inflammation index remained below baseline for up to 30 days after psilocybin therapy in people with Parkinson’s disease and mood dysfunction, researchers reported. The finding is an early biological signal, not proof that psilocybin reduces disease-related inflammation or improves health; the authors say it needs testing in larger randomized trials.
Ellen Bradley, MD, of the University of California, San Francisco, and colleagues studied 12 people aged 40 to 75 with mild-to-moderate Parkinson’s disease. Participants received oral synthetic psilocybin at doses of 10 mg and 25 mg, about two weeks apart. The trial was open-label, meaning participants and researchers knew the treatment being given, and it did not include a control group.
Blood samples were available from nine participants at baseline, one day after each dose, and 30 days after the 25-mg dose. The researchers assessed systemic inflammation using a combined index based on five markers: interleukin-6, interleukin-8, tumor necrosis factor alpha, interferon gamma and high-sensitivity C-reactive protein. Compared with baseline, the index was lower one day after 10 mg (standardized mean difference, or SMD, -0.72; adjusted P=0.003), one day after 25 mg (SMD -0.60; adjusted P=0.02), and 30 days after 25 mg (SMD -0.62; adjusted P=0.047).
Changes in individual markers did not all persist. Interleukin-6 was significantly lower and interleukin-10 higher one day after the 10-mg dose, but neither result remained significant at later measured time points. The mitochondrial stress marker GDF-15 was lower one day after each dose, but not at the 30-day measurement. FGF-21 rose after each dose, but the increases were not statistically significant.
A Biological Signal, Not a Treatment Finding
The results add preliminary evidence about how psilocybin may affect the body in people with a neurological condition, rather than only mental health outcomes. If later studies confirm the changes and connect them to patient outcomes, the findings could help researchers investigate biological pathways involved in potential effects of psychedelic therapy.
That possibility remains unproven. The trial measured blood markers, not whether inflammation in the brain changed, whether Parkinson’s progression slowed, or whether the marker shifts caused any improvement in mood or movement. A difference from baseline in a small group can also reflect factors other than the drug. The findings should not be read as evidence that psilocybin treats Parkinson’s disease.
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How the Parkinson’s Study Was Run
The biomarker analysis was reported by Bradley and co-authors in a research letter in JAMA Psychiatry. It was part of a parent trial that, according to the report, had found an association between psilocybin therapy and reductions in depression, anxiety and motor symptoms among Parkinson’s patients. The biomarker results do not by themselves establish that the clinical changes were caused by psilocybin or that inflammation changes explain them.
Bradley described the work to MedPage Today as, to the researchers’ knowledge, the first report of changes in these types of markers after psychedelic treatment in people with a neurodegenerative disease. Albert Garcia-Romeu, a Johns Hopkins University researcher who was not involved, said the study extends research beyond psychiatric conditions. His comments describe the potential significance of the work, not confirmation of a therapeutic effect.
“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, speaking to MedPage Today
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What the Biomarker Results Cannot Show
The small sample, lack of randomization and absence of a comparison group limit what can be concluded. Only nine participants provided samples for the reported analysis, and the study cannot distinguish treatment effects from other influences on blood markers. It also does not establish whether changes lasted beyond the measured 30-day follow-up.
Researchers have not shown that these systemic markers reflect inflammation in the brain, predict disease progression or account for changes in depression, anxiety or motor symptoms. The report does not establish an effective dose, long-term safety, or whether the findings apply to Parkinson’s patients without mood dysfunction. Those questions require further study.
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Randomized Follow-Up Underway
O’Donovan told MedPage Today that the 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 study should offer a stronger test of whether the changes seen in the initial group are associated with psilocybin rather than other factors.
The source report did not provide a completion date or results timeline for the Parkinson’s follow-up. Garcia-Romeu also described a separate study of psilocybin in people with mild cognitive impairment or early-stage Alzheimer’s disease and depression. He said 18 participants had been treated, 19 of a planned 20 had enrolled, and the team expected to complete the trial and publish findings the following year.
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Key Questions
What did the Parkinson’s trial find?
The researchers reported that a combined systemic inflammation index was lower than baseline at three measured follow-ups after psilocybin. The study included 12 participants, with blood samples available from nine.
Did psilocybin reduce Parkinson’s symptoms?
This biomarker analysis does not establish that psilocybin reduced symptoms. The report says the parent trial found an association with changes in depression, anxiety and motor symptoms, but the small, nonrandomized study cannot establish cause and effect.
How long did the marker changes last?
The combined inflammation index remained below baseline at the 30-day measurement after the 25-mg dose. The GDF-15 reduction was not present at that time point, and the study did not report follow-up beyond 30 days.
What happens next?
The UCSF researchers are conducting a randomized controlled follow-up trial with more detailed analyses of inflammation and mitochondrial stress. The source report did not give a date for its results.
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