Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study
This is the first modern study (n=12) on psilocybin and its effects on treatment-resistant depression (TRD). It shows that two sessions with psilocybin (10mg and 25mg) in combination with psychological support can reduce depressive symptoms over periods of one week to three months after treatment. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred.
Authors
- James Rucker
- Robin Carhart-Harris
- David Nutt
Published
Abstract
Background
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.
Methods
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 the 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.
Findings
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.
Interpretation
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.
Research Summary of 'Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study'
Introduction
Psilocybin is a naturally occurring psychedelic prodrug of psilocin that produces its principal psychoactive effects via serotonin 2A (5-HT2A) receptor agonism. Earlier preclinical and human imaging work has linked 5-HT2A receptor agonism with cognitive and neural plasticity changes and with antidepressant-like effects, and modern clinical studies of psychedelics have reported reductions in anxiety, depressive symptoms, and addictive behaviours after one or two exposures. At the same time, depression remains a major global health burden and a substantial minority of patients do not respond to available treatments, creating a need for new interventions for treatment-resistant depression. Carhart-Harris and colleagues designed this open-label feasibility study to assess whether a protocol of two supervised oral psilocybin administrations, given with psychological support, could be safely delivered to patients with unipolar treatment-resistant major depression and to obtain an initial impression of clinical effects. Their prespecified primary feasibility outcome was patient-rated subjective intensity of psilocybin's effects; the principal efficacy endpoint was change in self-reported depressive symptoms (16-item QIDS) from baseline to 1 week after the high-dose session. The investigators hypothesised that the intervention would be well tolerated and produce substantial reductions in depressive symptoms lasting up to 3 months.
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Study Details
- Study Typeindividual
- Journal
- Compound
- TopicsAnxiety DisordersDepressive DisordersAdolescentsMajor Depressive Disorder (MDD)Treatment-Resistant Depression (TRD)Obsessive-Compulsive Disorder (OCD)Alcohol Use Disorder (AUD)Tobacco/Nicotine Use Disorder (TUD)Substance Use Disorders (SUD)Headache Disorders (Cluster & Migraine)Palliative & End-of-Life DistressSafety & Risk ManagementChronic Pain
- Authors
- APA Citation
Carhart-Harris, R. L., Bolstridge, M., Rucker, J., Day, C. M. J., Erritzoe, D., Kaelen, M., Bloomfield, M., Rickard, J. A., Forbes, B., Feilding, A., Taylor, D., Pilling, S., Curran, V. H., & Nutt, D. J. (2016). Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry, 3(7), 619-627. https://doi.org/10.1016/S2215-0366(16)30065-7
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