Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness
This parallel-group, double-blinded, randomised controlled trial (n=35) investigates a single 25 mg oral psilocybin dose plus structured psychotherapy versus active placebo (100 mg niacin) for depression and anxiety in terminally ill patients.
Details
Parallel-group, randomised, double-blinded RCT (part 1) followed by an open-label phase (part 2); participants receive either 25 mg psilocybin or 100 mg niacin in the RCT, then all receive open-label psilocybin for the second dose.
Psychotherapy is provided before, during and after dose sessions: 11 sessions in total including two dose days, with preparatory sessions (3 before dose 1), integrative/preparatory sessions (3 between dose 1 and dose 2), and integrative sessions after dose 2. Sessions last up to 2 hours; dose days up to 8 hours.
Outcomes include changes in depression and anxiety (HADS), death anxiety (DAP-R), quality of life, spiritual wellbeing, demoralisation, and qualitative interview data; follow-up continues to 26 weeks post dose two.