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

Overview of attention for article published in The Lancet Psychiatry, May 2016
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Title
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study
Published in
The Lancet Psychiatry, May 2016
DOI 10.1016/s2215-0366(16)30065-7
Pubmed ID
Authors

Robin L Carhart-Harris, Mark Bolstridge, James Rucker, Camilla M J Day, David Erritzoe, Mendel Kaelen, Michael Bloomfield, James A Rickard, Ben Forbes, Amanda Feilding, David Taylor, Steve Pilling, Valerie H Curran, David J Nutt, Carhart-Harris, Robin L, Bolstridge, Mark, Rucker, James, Day, Camilla M J, Erritzoe, David, Kaelen, Mendel, Bloomfield, Michael, Rickard, James A, Forbes, Ben, Feilding, Amanda, Taylor, David, Pilling, Steve, Curran, Valerie H, Nutt, David J, Carhart-Harris, RL, Bolstridge, M, Rucker, J, Day, CM, Erritzoe, D, Kaelen, M, Bloomfield, M, Rickard, JA, Forbes, B, Feilding, A, Taylor, D, Pilling, S, Curran, VH, Nutt, DJ

Abstract

Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression. In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797. Psilocybin's acute psychedelic effects typically became detectable 30-60 min after dosing, peaked 2-3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0-1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1 week (mean QIDS difference -11·8, 95% CI -9·15 to -14·35, p=0·002, Hedges' g=3·1) and 3 months (-9·2, 95% CI -5·69 to -12·71, p=0·003, Hedges' g=2) after high-dose treatment. Marked and sustained improvements in anxiety and anhedonia were also noted. This study provides preliminary support for the safety and efficacy of psilocybin for treatment-resistant depression and motivates further trials, with more rigorous designs, to better examine the therapeutic potential of this approach. Medical Research Council.

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Geographical breakdown

Country Count As %
Denmark 2 1%
India 1 <1%
Portugal 1 <1%
Switzerland 1 <1%
Australia 1 <1%
United Kingdom 1 <1%
Brazil 1 <1%
United States 1 <1%
Unknown 180 95%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 44 23%
Researcher 38 20%
Student > Master 28 15%
Student > Ph. D. Student 24 13%
Other 18 10%
Other 37 20%
Readers by discipline Count As %
Medicine and Dentistry 56 30%
Psychology 46 24%
Neuroscience 26 14%
Biochemistry, Genetics and Molecular Biology 12 6%
Agricultural and Biological Sciences 12 6%
Other 37 20%