A psilocybin feasibility trial for treatment-resistant depression, run inside the English NHS

A randomized, double-blind, placebo-controlled phase 2 feasibility trial ran at one National Health Service site in England. It enrolled 60 adults with treatment-resistant major depressive disorder and followed them for six weeks after a single dosing day.

Recruitment, retention and scores

Of 75 people who consented to screening, 62 were eligible and 60 were randomized, 30 to each arm. All 60 attended the dosing visit, and 59 completed the MADRS at every follow-up; the one missing participant was in the placebo arm and withdrew before week 1. Adjusted between-group differences favored psilocybin at each time point: -11.44 at week 1 (95% CI -15.89 to -6.98), -10.41 at week 3 (-14.86 to -5.95) and -12.92 at week 6 (-17.37 to -8.47). At week 3, 13 participants (43%) in the psilocybin arm and 1 (3%) in the placebo arm met the MADRS response criterion; remission was 12 (40%) against 1 (3%). The authors call these effect sizes preliminary.

The frame around the session

Participants went through a preparation phase of one to eight weeks that included psychoeducation sessions with a trial therapist, then a dosing day of about six hours with a therapist present, then four time-limited integration visits at 1 day, 1 week, 3 weeks and 6 weeks. Visits began in a hospital clinical research facility; halfway through recruitment they moved to a refurbished community mental health team setting, which the authors call a natural test of deliverability.

For a practitioner, the transferable part of this model is the frame: a defined preparation period, scheduled follow-up contacts and a therapist's continuous presence on the session day. The drug itself and the medical decision to discharge at the end of the day belong to the protocol and to a licensed medical team. The paper treats licensing and funding as still to be settled.