An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome
This open-label trial (n=10) will examine low-dose psilocybin as a safe treatment alternative for Fragile X Syndrome (FXS), aiming to improve markers of cognition, communication, mood, behaviour, neuroinflammation, serotonin levels in exosomes, and neuroplasticity.
Details
Phase II, open-label, single-group feasibility study of low-dose psilocybin (1.5 mg capsules) administered every other day for 28 days in adults with Fragile X syndrome (n=10).
Assessments include clinician- and caregiver-reported measures (VABS-3, CGI-I, ADAMS, VAS-TS), cognitive tests (NIH-TCB, TMT, MET), safety monitoring (DOA, ECG, vitals) and biomarkers (saliva/buccal swabs, neuroinflammation and serotonin markers in exosomes).
Drug dispensed in blister packs weekly; adherence monitored, unused study medication returned at visits; subjects attend visits at baseline and days 8, 15, 22 and 28.