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

This single-masked, randomised controlled trial (n=60) will evaluate the effectiveness of psilocybin (5-6g per session*, two doses six weeks apart) and psilocybin-assisted cognitive behavioural therapy (CBT) in treating major depressive disorder (MDD).

The study, conducted by Khyber Medical University Peshawar, will compare four groups: conventional therapy, psilocybin therapy, CBT, and psilocybin-assisted CBT. Over ten weeks, participants will continue their routine antidepressant medications while undergoing assessments for changes in depression symptoms, inflammatory and neurochemical markers, and brain activity via EEG. Depression severity will be measured using validated scales (HAM-D, MADRS, and BDI).

The primary objective is to determine whether psilocybin alone or combined with CBT offers superior antidepressant effects compared to conventional treatments. Secondary outcomes include evaluating immune and inflammatory responses, neuroplasticity, and brain function changes.

*though not defined – the trial authors probably mean psilocybin-containing mushrooms (not psilocybin-only, this would be 100x too high of a dose).

Trial Details

This randomized controlled clinical trial evaluates the effectiveness of psilocybin and psilocybin-assisted cognitive behavioral therapy (CBT) in the management of Major Depressive Disorder (MDD). The study aims to compare the effects of psilocybin-only therapy, CBT, and psilocybin-assisted CBT on depression symptoms, neurochemical markers, inflammatory markers, and neuroplasticity in individuals with MDD. Participants will continue their routine depression medications and will be assessed for changes in depression scores, biochemical markers, and brain activity patterns using validated tools and tests.

Trial Number NCT06746441

Data attribution

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