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Psilocybin with psychological support for treatment-resistant depression: six-month follow-up
R. L. Carhart-Harris M. Bolstridge C.M.J. Day J. Rucker R. Watts David Erritzoe M. Kaelen B. Giribaldi M. A P Bloomfield S. Pilling
R. L. Carhart-Harris
M. Bolstridge
C.M.J. Day
J. Rucker
R. Watts
David Erritzoe
M. Kaelen
B. Giribaldi
M. A P Bloomfield
S. Pilling
Abstract
Rationale
Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy.
Objectives
Here, we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression.
Methods
Twenty patients (six females) with (mostly) severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 and 25 mg, 7 days apart) in a supportive setting. Depressive symptoms were assessed from 1 week to 6 months post-treatment, with the self-rated QIDS-SR16 as the primary outcome measure.
Results
Treatment was generally well tolerated. Relative to baseline, marked reductions in depressive symptoms were observed for the first 5 weeks post-treatment (Cohen’s d = 2.2 at week 1 and 2.3 at week 5, both p < 0.001); nine and four patients met the criteria for response and remission at week 5. Results remained positive at 3 and 6 months (Cohen’s d = 1.5 and 1.4, respectively, both p < 0.001). No patients sought conventional antidepressant treatment within 5 weeks of psilocybin. Reductions in depressive symptoms at 5 weeks were predicted by the quality of the acute psychedelic experience.
Conclusions
Although limited conclusions can be drawn about treatment efficacy from open-label trials, tolerability was good, effect sizes large and symptom improvements appeared rapidly after just two psilocybin treatment sessions and remained significant 6 months post-treatment in a treatment-resistant cohort. Psilocybin represents a promising paradigm for unresponsive depression that warrants further research in double-blind randomised control trials.
Keywords
serotonin, 5-HT2AR, depression, treatment-resistant depression, psilocybin, psychedelic, mood, hallucinogen, psychotherapy
Date
2018
Type
Journal article
Journal
Psychopharmacology
Book
Volume
235
Issue
2
Page Range
399-408
Article Number
ACU Department
School of Behavioural and Health Sciences
Faculty of Health Sciences
Faculty of Health Sciences
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
CC BY 4.0
File Access
Open