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Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial

Annie Umbricht, Mary P Cosimano, Roland R. Griffiths, Matthew W. Johnson, Michael A. Carducci, William A. Richards, Brian D. Richards, Margaret A Klinedinst

Journal of Psychopharmacology November 30, 2016 DOI: 10.1177/0269881116675513 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Double-blind Peer reviewed
Sample size 51
Population Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety
Intervention Psilocybin
Dose 1 or 3 mg/70 kg (very low dose) vs. 22 or 30 mg/70 kg (high dose)
Duration 5 weeks between sessions, 6-month follow-up
Topics Anxiety Psilocybin Depression
Keywords Mood Randomized controlled trial Placebo Clinical psychology
Citations 2,174
Registration NCT00465595
Key findings High-dose psilocybin produced large and sustained decreases in depressed mood and anxiety, with about 80% of participants showing clinically significant improvement at 6-month follow-up.

Abstract

Cancer patients often develop chronic, clinically significant symptoms of depression and anxiety. Previous studies suggest that psilocybin may decrease depression and anxiety in cancer patients. The effects of psilocybin were studied in 51 cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety. This randomized, double-blind, cross-over trial investigated the effects of a very low (placebo-like) dose (1 or 3 mg/70 kg) vs. a high dose (22 or 30 mg/70 kg) of psilocybin administered in counterbalanced sequence with 5 weeks between sessions and a 6-month follow-up. Instructions to participants and staff minimized expectancy effects. Participants, staff, and community observers rated participant moods, attitudes, and behaviors throughout the study. High-dose psilocybin produced large decreases in clinician- and self-rated measures of depressed mood and anxiety, along with increases in quality of life, life meaning, and optimism, and decreases in death anxiety. At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the high-dose experience, with >80% endorsing moderately or greater increased well-being/life satisfaction. Community observer ratings showed corresponding changes. Mystical-type psilocybin experience on session day mediated the effect of psilocybin dose on therapeutic outcomes. Trial Registration ClinicalTrials.gov identifier: NCT00465595

In the evidence

This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.

  • High-dose psilocybin produced large decreases in clinician- and self-rated anxiety and depressed mood, with about 80% showing clinically significant improvement sustained at 6 months.

    Synthesized

  • High-dose psilocybin produced large and sustained decreases in depressed mood and anxiety, with about 80% of participants showing clinically significant improvement at 6-month follow-up.

    Synthesized

  • High-dose psilocybin produced large and sustained decreases in anxiety and depression, with about 80% of participants showing clinically significant improvement at 6-month follow-up.

    Synthesized

  • High-dose psilocybin produced large and sustained decreases in depressed mood and anxiety, with about 80% of participants showing clinically significant improvement at 6-month follow-up.

    Synthesized

Comparable studies

Other randomized controlled trials on psilocybin for anxiety, most cited first.

Study Year Design Participants
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... 2006 Double-blind study n = 36
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Adults with advanced-stage cancer and anxiety 2010 Double-blind, placebo-controlled study n = 12
Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies Healthy human subjects 2010 Pooled analysis of double-blind placebo-controlled experimental studies n = 110
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up Patients aged 21–75 with moderate to severe unipolar depression 2022 Randomized waiting-list controlled study n = 27

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