Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers
Single-masked, randomised controlled trial (n=60) comparing psilocybin (two high-dose oral sessions, 5–6 g each, six weeks apart), CBT (8–10 sessions), psilocybin-assisted CBT, and routine care in adults with MDD.
Details
This randomized, single-masked, parallel-group trial will randomize 60 adults with DSM‑V major depressive disorder to one of four arms: routine care, psilocybin only, CBT only, or psilocybin-assisted CBT. Psilocybin is given in two oral sessions six weeks apart; CBT comprises 8–10 structured 90‑minute sessions.
Outcomes include change in depressive symptoms (HAM‑D, MADRS, BDI), immune and inflammatory markers (CD4/CD8, TNF‑α, IL‑6, resistin, visfatin), neuroplasticity markers (BDNF, oxytocin) and EEG measures; analyses will use ANOVA with Tukey post‑hoc tests.