Psilocybin-induced neurocardiogenic syncope: a case report.

Area of Science:

• Psychiatry and Neuroscience
• Clinical Pharmacology
• Medical Imaging and Neurostimulation

Background:

• Psilocybin shows therapeutic promise for psychiatric conditions and is nearing FDA approval.
• Systematic adverse event (AE) characterization is crucial as psilocybin clinical trials expand.
• While hypertensive responses are documented, hypotensive events like neurocardiogenic syncope (NCS) are rarely reported.

Purpose of the Study:

• To report a rare case of neurocardiogenic syncope (NCS) during psilocybin administration in a clinical trial.
• To emphasize the importance of cardiovascular monitoring during psilocybin administration, especially in conjunction with other procedures.
• To advocate for transparent reporting of all adverse events (AEs), both hypertensive and hypotensive, to define psilocybin's safety profile.

Main Methods:

• Case report of a healthy 35-year-old male participant in an open-label psilocybin study.
• Psilocybin (25 mg oral) administered during transcranial magnetic stimulation and electroencephalography (TMS-EEG) monitoring.
• Detailed recording of physiological responses, including blood pressure, heart rate, and subjective experiences, during the event.

Main Results:

• The participant experienced neurocardiogenic syncope (NCS) approximately 60 minutes post-psilocybin administration.
• Immediate post-event vitals: blood pressure 93/51 mmHg, with tachycardia and diaphoresis.
• Rapid stabilization achieved with supportive measures (leg elevation, hydration); no further cardiovascular abnormalities observed.

Conclusions:

• This case highlights a rare hypotensive adverse event (AE) associated with psilocybin.
• Vigilant cardiovascular monitoring is essential during psilocybin administration, particularly with procedures inducing emotional arousal.
• Systematic AE assessment and transparent reporting are critical for psilocybin's expanding clinical applications.