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Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study

Carhart-Harris RL, Bolstridge M, Rucker J, et al. The Lancet Psychiatry 2016;3(7):619-27

Clinical trialPsilocybintreatment-resistant depression

This small UK study checked whether psilocybin could be given safely and practically to people with depression that had not responded to other treatments. Twelve patients took a 10 mg dose and, a week later, a 25 mg dose, with psychological support throughout. Everyone knew they were getting psilocybin and there was no comparison group. The drug was well tolerated: brief anxiety as effects began was universal, and some people had temporary confusion, nausea or headache, but there were no serious adverse events. Depression scores dropped sharply one week after the higher dose and were still clearly lower at three months. Because there was no placebo or control and the group was small, the results show feasibility and justify proper trials rather than proving effectiveness.

What it found

  • Psilocybin was well tolerated; no serious or unexpected adverse events
  • All patients had transient anxiety at onset; nine had transient confusion, four mild nausea and four headache
  • Depression scores (QIDS) fell by a mean 11.8 points at 1 week and 9.2 points at 3 months after the high dose
  • Anxiety and anhedonia also improved
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