Journal Article

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

Day, C. M. J., Rucker, J., Pilling, S., Feilding, A., Giribaldi, B., Erritzoe, D. E., Rickard, J. A., Forbes, B., Bloomfield, M., Curran, H. V., Nutt, D. J., Watts, R., Taylor, D., Carhart-Harris, R. L., Bolstridge, M., Kaelen, M.

2018

Overview

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.

• Publisher: Springer Berlin Heidelberg,Springer,Springer Nature B.V
• Subject: Adult / Antidepressive Agents - therapeutic use / Biomedical and Life Sciences / Biomedicine / Care and treatment / Clinical outcomes / Clinical trials / Combined Modality Therapy / Depression (Mood disorder) / Depressive Disorder, Treatment-Resistant - diagnosis / Depressive Disorder, Treatment-Resistant - drug therapy / Depressive Disorder, Treatment-Resistant - psychology / Dosage and administration / Double-Blind Method / Feasibility Studies / Female / Follow-Up Studies / Hallucinogenic drugs / Hallucinogens - therapeutic use / Humans / Male / Mental depression / Mental disorders / Methods / Middle Aged / Neurosciences / Original Investigation / Patient outcomes / Pharmacology/Toxicology / Psilocybin / Psilocybin - therapeutic use / Psychedelic drugs / Psychiatry / Psychopharmacology / Psychosocial Support Systems / Psychotherapy / Remission / Time Factors / Treatment Outcome / Treatment resistance