The role of childhood trauma on psilocybin outcomes for adults with treatment-resistant depression: A secondary analysis of the PsiDeR trial.
Abstract
This is a secondary data analysis using data obtained from the Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) trial, a parallel group, two arm, double-blind, randomised, placebo-controlled, between-subjects, single centre, phase 2 trial that evaluated the feasibility and safety of psilocybin, given with psychological support. Sixty adults with treatment-resistant depression (TRD), defined as nonresponse or intolerance to at least two-evidence based treatments for major depressive disorder, were randomly assigned in a ratio of 1:1 to either the treatment or placebo arm. Those assigned to the treatment arm received a single dose of psilocybin (25 mg), while those assigned to the placebo arm received inactive placebo (starch 1500). This secondary analysis will investigate whether a history of childhood trauma influences psilocybin outcomes, including changes in depression symptom severity, anxiety symptom severity, cognitive functioning, emotional recognition, mental wellbeing, and quality of life.
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