Psilocybin with psychological support for treatment-resistant depression: six-month follow-up

By Robin L. Carhart-Harris, M. Bolstridge, Camilla M. Day, James Rucker, R. Watts, D. Erritzoe, M. Kaelen, B. Giribaldi, M. Bloomfield, S. Pilling and 6 more. Psychopharmacology, 2017

851 citations recorded by the source corpus.

Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy. Here, we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression. 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. 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. 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.

Subfields: Clinical Psychology, Cognitive Neuroscience, Toxicology

View Paper: https://www.semanticscholar.org/paper/54241eed73a6a87c456f4b880ffcb168b50851f0

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Citations in the corpus

The Therapeutic Potential of Psychedelic Drugs: Past, Present, and Future (2017, background): “…clinical development of psychedelics, RLC-H sees it as a potentially exploitable component—especially as it has been shown to be predictive of long-term clinical outcomes (eg, in Johnson et al, 2014; Bogenschutz et al, 2015; Griffiths et al, 2016; Ross et al, 2016; Carhart-Harris et al, 2016a,b).”
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression (2018, background): “We recently completed an open-label clinical trial assessing the feasibility of treating 20 patients with treatment-resistant depression (TRD) with psilocybin (Carhart-Harris et al., 2017).”
REBUS and the Anarchic Brain: Toward a Unified Model of the Brain Action of Psychedelics (2019, methodology): “If mediated properly, this belief – recalibration process may have long-term positive consequences for mental health; indeed, the described process is the very essence of effective psychedelic therapy (Haijen et al., 2018; Lyons and Carhart-Harris, 2018b).”