Psilocybin – Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Double-blind, randomised, placebo-controlled crossover Phase I study (n=18) with two dosing sessions ~4 weeks apart comparing placebo, low-dose psilocybin (0.1 mg/kg) and medium-dose psilocybin (0.3 mg/kg) in people with major depressive disorder to assess neuroplasticity and symptom change.
Details
This randomised, double-blind crossover study enrolls 18 participants with Major Depressive Disorder to receive two of three interventions across two sessions (~4 weeks apart): placebo, low-dose psilocybin (0.1 mg/kg) or medium-dose psilocybin (0.3 mg/kg). The primary purpose is treatment and to evaluate psilocybin-induced neuroplasticity alongside clinical response.
Outcomes include neuroimaging and biomarkers of plasticity and clinical measures of depression; standard safety monitoring and urine toxicology are used. Participants must have failed at least one adequate antidepressant trial and be engaged with a mental health clinician.