Trial PaperAnxiety DisordersDepressive DisordersMajor Depressive Disorder (MDD)Treatment-Resistant Depression (TRD)Obsessive-Compulsive Disorder (OCD)Substance Use Disorders (SUD)Palliative & End-of-Life DistressPsilocybin

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

This open-label study (n=20) expands on earlier work by Carhart-Harris and colleagues on the use of psilocybin-assisted therapy for treatment-resistant depression (TRD).

Authors

  • James Rucker
  • Robin Carhart-Harris
  • David Nutt

Published

Psychopharmacology
individual Study

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.

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Research Summary of 'Psilocybin with psychological support for treatment-resistant depression: six-month follow-up'

Introduction

Psilocybin, a naturally occurring serotonergic psychedelic, has been investigated for a range of psychiatric indications and prior trials have reported improvements in depressive symptoms following psilocybin‑assisted psychotherapy. Previous work has also suggested therapeutic potential for other serotonergic psychedelics in conditions such as obsessive–compulsive disorder, addiction and anxiety related to terminal illness, and mechanistic interest centres on 5‑HT2A receptor agonism. Earlier clinical and historical studies, as well as laboratory findings, indicate both promise and complexity in how 5‑HT2A signalling relates to antidepressant effects. Carhart‑Harris and colleagues present an extension of their earlier pilot study in treatment‑resistant depression, increasing the sample from 12 to 20 patients and lengthening follow‑up from 3 to 6 months. The paper reports safety and efficacy outcomes from an open‑label feasibility trial in which two oral psilocybin doses were administered with structured psychological support; the main aim was to assess symptom change over time, tolerability and relationships between acute subjective experiences and longer‑term clinical outcomes.

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Study Details

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Doyle, M. A., Ling, S., Lui, L. M. W. et al. · Expert Opinion on Drug Safety (2022)

The Effects of Psilocybin in Adults with Major Depressive Disorder and The General Population

Gill, H., Puramat, P., Patel, P. et al. · Psychiatry Research (2022)

Differences in personality, cognitive abilities, illicit drug use, and white matter structural integrity between hallucinogen users and matched controls

Aharon-Almagor, A., Barrett, F. S. · Research Square (2022)

Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression

Murphy, R., Murphy-Beiner, A., Kettner, H. et al. · Frontiers in Pharmacology (2022)

162 cited
Towards psychedelic apprenticeship: Developing a gentle touch for the mediation and validation of psychedelic-induced insights and revelations

Timmermann, C., Watts, R., Dupuis, D. · Transcultural Psychiatry (2022)

95 cited
Effects of Naturalistic Psychedelic Use on Depression, Anxiety, and Well-Being: Associations With Patterns of Use, Reported Harms, and Transformative Mental States

Raison, C. L., Jain, R., Jain, S. et al. · Frontiers in Psychiatry (2022)

59 cited
Psilocybin-Induced Mystical-Type Experiences are Related to Persisting Positive Effects: A Quantitative and Qualitative Report

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79 cited
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up

Davis, A. K., Streeter Barrett, F., Cosimano, M. P. et al. · Journal of Psychopharmacology (2022)

306 cited
Trajectory of Antidepressant Effects after Single- or Two-Dose Administration of Psilocybin: A Systematic Review and Multivariate Meta-Analysis

Yu, C. L., Liang, C. S., Yang, F. et al. · Journal of Clinical Medicine (2022)

Evaluating the Potential Use of Serotonergic Psychedelics in Autism Spectrum Disorder

Markopoulos, A., Inserra, A., De Gregorio, D. et al. · Frontiers in Pharmacology (2022)

30 cited
Biochemical Mechanisms Underlying Psychedelic-Induced Neuroplasticity

Olson, D. E. · Biochemistry (2022)

95 cited
Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia

Glynos, N. G., Pierce, J., Davis, A. K. et al. · Journal of Psychoactive Drugs (2022)

Validation of the Psychological Insight Scale: A new scale to assess psychological insight following a psychedelic experience

Peill, J. M., Trinci, K. E., Kettner, H. et al. · Journal of Psychopharmacology (2022)

The effects of psilocybin on cognitive and emotional functions in healthy participants: Results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation

Rucker, J. J., Marwood, L., Ajantaival, R. L. J. et al. · Journal of Psychopharmacology (2022)

Exploring the Credibility of Psilocybin-assisted Therapy and Cognitive-behavioral Therapy for Depression

Altman, B. R., Earleywine, M., De Leo, J. · Journal of Psychoactive Drugs (2022)

4 cited
Effective Connectivity of LSD-induced Ego Dissolution

Stoliker, D., Novelli, L., Vollenweider, F. X. et al. · MedRvix (2021)

4 cited
Psychedelic Therapy's Transdiagnostic Effects: A Research Domain Criteria (RDoC) Perspective

Dursun, S. M., Kelly, J. R., Gillan, C. M. et al. · Frontiers in Psychiatry (2021)

A Spectrum of Selves Reinforced in Multilevel Coherence: A Contextual Behavioural Response to the Challenges of Psychedelic-Assisted Therapy Development

Whitfield, H. J. · Frontiers in Psychiatry (2021)

Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial

Rucker, J., Jafari, H., Mantingh, T. et al. · BMJ Open (2021)

Psilocybin, a Naturally Occurring Indoleamine Compound, Could Be Useful to Prevent Suicidal Behaviors

Strumila, R., Guillaume, S. · Pharmaceuticals (2021)

Acute effects of psilocybin after escitalopram or placebo pretreatment in a randomized, double-blind, placebo-controlled, cross-over study in healthy subjects

Becker, A. M., Holze, F., Grandinett, T. et al. · Clinical Pharmacology and Therapeutics (2021)

Psychedelic experience dose-dependently modulated by cannabis: results of a prospective online survey

Kuc, J., Kettner, H., Rosas, F. E. et al. · Psychopharmacology (2021)

A narrative synthesis of research with 5-MeO-DMT

Ermakova, A. O., Dunbar, F., Rucker, J. et al. · Journal of Psychopharmacology (2021)

Day trip to hell: A mixed methods study of challenging psychedelic experiences

Johnstad, P. G. · Journal of Psychedelic Studies (2021)

43 cited
A Qualitative Exploration of Relational Ethical Challenges and Practices in Psychedelic Healing

Brennan, W., Jackson, M. A., MacLean, K. A. · Journal of Humanistic Psychology (2021)

34 cited
Do Psychedelics Change Beliefs?

McGovern, H., Leptourgos, P., Hutchinson, B. et al. · Psyarxiv (2021)

Improving cognitive functioning in major depressive disorder with psychedelics: a dimensional approach

Kuiperes, Z., Schreiber, R. · Neurobiology of Learning and Memory (2021)

Psilocybin-induced changes in brain network integrity and segregation correlate with plasma psilocin level and psychedelic experience

Madsen, M. K., Stenbaek, D. S., Arvidsson, A. et al. · European Neuropsychopharmacology (2021)

Turn on, Tune in, and Drop out: Predictors of Attrition in a Prospective Observational Cohort Study on Psychedelic Use

Hübner, S., Haijen, E. C. H. M., Kaelen, M. et al. · Journal of Medical Internet Research (2021)

Does psychedelic therapy have a transdiagnostic action and prophylactic potential?

Kočárová, C., Horacek, J., Carhart-Harris, R. L. · Frontiers in Psychiatry (2021)

73 cited
Psilocybin as a Novel Pharmacotherapy for Treatment-Refractory Anorexia Nervosa

Rodan, S., Aouad, P., McGregor, I. S. et al. · OBM Neurobiology (2021)

Psychedelic perceptions: mental health service user attitudes to psilocybin therapy

Corrigan, K., Haran, M., Mccandliss, C. et al. · Irish Journal of Medical Science (2021)

Psilocybin and MDMA for the treatment of trauma-related psychopathology

Bird, C. I. V., Modlin, N. L., Rucker, J. · International Review of Psychiatry (2021)

Future Directions for Clinical Psilocybin Research: The Relaxed Symptom Network

Lewis-Healey, E., Laukkonen, R., Van Elk, M. · Psyarxiv (2021)

1 cited
Protocol for Outcome Evaluation of Ayahuasca-Assisted Addiction Treatment: The Case of Takiwasi Center

Rush, B., Marcus, O., García, S. et al. · Frontiers in Pharmacology (2021)

19 cited
Association Between Lifetime Classic Psychedelic Use and Hypertension in the Past Year

Simonsson, O., Hendricks, P. S., Carhart-Harris, R. et al. · Hypertension (2021)

28 cited
Clinical and biological predictors of psychedelic response in the treatment of psychiatric and addictive disorders: a systematic review

Romeo, B., Hermand, M., Pétillion, A. et al. · Journal of Psychiatric Research (2021)

60 cited
Trial of Psilocybin versus Escitalopram for Depression

Carhart-Harris, R. L., Giribaldi, B., Watts, R. et al. · New England Journal of Medicine (2021)

927 cited
Ethical and legal issues in psychedelic harm reduction and integration therapy

Pilecki, B., Luoma, J. B., Bathje, G. J. et al. · Harm Reduction Journal (2021)

Acute and Sustained Reductions in Loss of Meaning and Suicidal Ideation Following Psilocybin-Assisted Psychotherapy for Psychiatric and Existential Distress in Life-Threatening Cancer

Ross, E., Agin-Liebes, G. I., Zeifman, R. J. et al. · ACS Pharmacology and Translational Science (2021)

94 cited
Combining Psychedelic and Mindfulness Interventions: Synergies to Inform Clinical Practice

Payne, J. E., Chambers, R., Liknaitzky, P. · ACS Pharmacology and Translational Science (2021)

55 cited
On the Relationship between Classic Psychedelics and Suicidality: A Systematic Review

Zeifman, R. J., Singhal, N., Breslow, L. et al. · ACS Pharmacology and Translational Science (2021)

Associations between lifetime classic psychedelic use and markers of physical health

Simonsson, O., Sexton, J. D., Hendricks, P. S. · Journal of Psychopharmacology (2021)

65 cited
Dose-response relationships of psilocybin-induced subjective experiences in humans

Hirschfeld, T., Schmidt, T. T. · Journal of Psychopharmacology (2021)

Optimal dosing for psilocybin pharmacotherapy: Considering weight-adjusted and fixed dosing approaches

Garcia-Romeu, A., Barrett, F. S., Carbonaro, T. M. et al. · Journal of Psychopharmacology (2021)

Trends in the Top-Cited Articles on Classic Psychedelics

Lawrence, D. W., Sharma, B., Griffiths, R. R. et al. · Journal of Psychoactive Drugs (2021)

Lasting effects of a single psilocybin dose on resting-state functional connectivity in healthy individuals

McCulloch, D. E-W., Madsen, M. K., Stenbæk, D. S. et al. · Journal of Psychopharmacology (2021)

Classic serotonergic psychedelics for mood and depressive symptoms: a meta-analysis of mood disorder patients and healthy participants

Galvão-Coelho, N. L., Marx, W., Sinclair, J. et al. · Psychopharmacology (2021)

Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin

Schindler, E. A. D., Sewell, R. A., Gottschalk, C. H. et al. · Neurotherapeutics (2021)

Virtual Reality and Psychedelics for the Treatment of Psychiatric Disease: A Systematic Literature Review

Ortiz, M. I., Gómez-Busto, F. J. · Clinical Neuropsychiatry (2020)

Effect of lysergic acid diethylamide (LSD) on reinforcement learning in humans

Kanen, J. W., Luo, Q., Kandroodi, M. R. et al. · Psychological Medicine (2020)

Psilocybin-Assisted Group Therapy and Attachment: Observed Reduction in Attachment Anxiety and Influences of Attachment Insecurity on the Psilocybin Experience

Stauffer, C., Anderson, B. T., Ortigo, K. M. et al. · ACS Pharmacology and Translational Science (2020)

51 cited
Ketamine and Serotonergic Psychedelics: Common Mechanisms Underlying the Effects of Rapid-Acting Antidepressants

Kadriu, B., Greenwald, M., Ba et al. · International Journal of Neuropsychopharmacology (2020)

Therapeutic effects of classic serotonergic psychedelics: A systematic review of modern-era clinical studies

Andersen, K. A. A., Carhart-Harris, R. L., Nutt, D. J. et al. · Acta Psychiatrica Scandinavica (2020)

Rapid and sustained decreases in suicidality following a single dose of ayahuasca among individuals with recurrent major depressive disorder: results from an open-label trial

Zeifman, R. J., Dos Santos, R. G., Sanches, R. F. et al. · Psychopharmacology (2020)

67 cited
Post-acute psychological effects of classical serotonergic psychedelics: A systematic review and meta-analysis

Goldberg, S. B., Shechet, B., Nicholas, C. R. et al. · Psychological Medicine (2020)

Acute subjective effects in LSD- and MDMA-assisted psychotherapy

Schmid, Y., Gasser, P., Oehen, P. et al. · Journal of Psychopharmacology (2020)

72 cited
Brain serotonin 2A receptor binding predicts subjective temporal and mystical effects of psilocybin in healthy humans

Stenbæk, D. S., Madsen, M. K., Ozenne, B. et al. · Journal of Psychopharmacology (2020)

Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study

Anderson, B. T., Danforth, A. L., Daroff, R. et al. · EClinicalMedicine (2020)

212 cited
Psychedelic drugs: neurobiology and potential for treatment of psychiatric disorders

Vollenweider, F. X., Preller, K. H. · Nature Reviews Neuroscience (2020)

Transient Stimulation with Psychoplastogens Is Sufficient to Initiate Neuronal Growth

Greb, A. C., Vargas, M. V., Duim, W. C. et al. · ACS Pharmacology and Translational Science (2020)

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials

Vargas, A. S., Luís, Â., Barroso, M. et al. · Biomedicines (2020)

The therapeutic potential of microdosing psychedelics in depression

Kuypers, K. P. C. · Therapeutic Advances in Psychopharmacology (2020)

Psychedelics and virtual reality: parallels and applications

Aday, J. S., Davoli, C. C., Bloesch, E. K. · Therapeutic Advances in Psychopharmacology (2020)

Post-Psychedelic Reductions in Experiential Avoidance Are Associated With Decreases in Depression Severity and Suicidal Ideation

Zeifman, R. J., Wagner, A. C., Watts, R. et al. · Frontiers in Psychiatry (2020)

82 cited
Mystical Experiences in Retrospective Reports of First Times Using a Psychedelic in Finland

Kangaslampi, S., Hausen, A., Rauteenmaa, T. · Journal of Psychoactive Drugs (2020)

Ethics and ego dissolution: the case of psilocybin

Smith, W. R., Sisti, D. · Journal of Medical Ethics (2020)

Psychedelic treatment of functional neurological disorder: a systematic review

Butler, M., Seynaeve, M., Nicholson, T. R. et al. · Therapeutic Advances in Psychopharmacology (2020)

Isness: Using Multi-Person VR to Design Peak Mystical Type Experiences Comparable to Psychedelics

Glowacki, D. R., Wonnacott, M. D., Freire, R. et al. · Association for Computing Machinery (2020)

32 cited
A single psilocybin dose is associated with long-term increased mindfulness, preceded by a proportional change in neocortical 5-HT2A receptor binding

Madsen, M. K., Fisher, P. M., Stenbæk, D. S. et al. · European Neuropsychopharmacology (2020)

Depression, Mindfulness, and Psilocybin: Possible Complementary Effects of Mindfulness Meditation and Psilocybin in the Treatment of Depression. A Review

Heuschkel, K., Kuypers, K. P. C. · Frontiers in Psychiatry (2020)

63 cited
Long-term effects of psychedelic drugs: A systematic review

Aday, J. S., Mitzkovitz, C. M., Bloesch, E. K. et al. · Neuroscience and Biobehavioral Reviews (2020)

Effects of ayahuasca on mental health and quality of life in naïve users: A longitudinal and cross-sectional study combination

Jiménez-Garrido, D. F., Gómez-Sousa, M., Ona, G. et al. · Scientific Reports (2020)

Natural Psychoplastogens As Antidepressant Agents

Benko, J., Vranková, S. · Molecules (2020)

Learning to Let Go: A Cognitive-Behavioral Model of How Psychedelic Therapy Promotes Acceptance

Wolff, M., Evens, R., Mertens, L. J. et al. · Frontiers in Psychiatry (2020)

Rostral Anterior Cingulate Thickness Predicts the Emotional Psilocybin Experience

Lewis, C. R., Preller, K. H., Braden, B. B. et al. · Biomedicines (2020)

24 cited
Acute effects of psilocybin on glutamate concentration levels, functional connectivity and subjective state

Mason, N. L., Feilding, A., Ramaekers, J. G. · European Neuropsychopharmacology (2020)

The experimental effects of psilocybin on symptoms of anxiety and depression: A meta-analysis

Goldberg, S. B., Pace, B. T., Nicholas, C. R. et al. · Psychiatry Research (2020)

Persisting Reductions in Cannabis, Opioid, and Stimulant Misuse After Naturalistic Psychedelic Use: An Online Survey

Garcia-Romeu, A., Davis, A. K., Griffiths, R. R. et al. · Frontiers in Psychiatry (2020)

121 cited
Classic psychedelics as therapeutics for psychiatric disorders

Nichols, C. D., Hendricks, P. S. · Handbook of Behavioral Neuroscience (2020)

Microdosing psychedelics: Motivations, subjective effects and harm reduction

Lea, T., Amada, N., Jungaberle, H. et al. · International Journal of Drug Policy (2020)

95 cited
From Egoism to Ecoism: Psychedelics Increase Nature Relatedness in a State-Mediated and Context-Dependent Manner

Kettner, H., Gandy, S., Haijen, E. C. H. M. et al. · International Journal of Environmental Research and Public Health (2019)

131 cited
The Impact of Ayahuasca on Suicidality: Results From a Randomized Controlled Trial.

Araújo, D. B., Zeifman, R. J., Palhano-Fontes, F. et al. · Frontiers in Pharmacology (2019)

96 cited
Characterization and prediction of acute and sustained response to psychedelic psilocybin in a mindfulness group retreat

Smigielski, L., Kometer, M., Scheidegger, M. et al. · Scientific Reports (2019)

126 cited
Toward a contextual psychedelic-assisted therapy: Perspectives from Acceptance and Commitment Therapy and contextual behavioral science

Luoma, J. B., Sabucedo, P., Eriksson, J. et al. · Journal of Contextual Behavioral Science (2019)

Psychedelic microdosing benefits and challenges: an empirical codebook

Anderson, T., Petranker, R., Christopher, A. et al. · Harm Reduction Journal (2019)

Psychedelic drugs-a new era in psychiatry?

Nutt, D. J. · Dialogues in Clinical Neuroscience (2019)

Serotonergic hallucinogens and recognition of facial emotion expressions: a systematic review of the literature.

Rocha, J. M., Osório, F. L., Crippa, J. A. et al. · Therapeutic Advances in Psychopharmacology (2019)

Psychedelic medicine: The biology underlying the persisting psychedelic effects

Kuypers, K. P. C. · Medical Hypotheses (2019)

How do psychedelics work?

Carhart-Harris, R. L. · Current Opinion in Psychiatry (2019)

3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress dis - order: a randomized phase 2 controlled trial

Ot'alora G, M., Grigsby, J., Poulter, B. et al. · Journal of Psychopharmacology (2018)

182 cited
More realistic forecasting of future life events after psilocybin for treatment-resistant depression

Lyons, T., Carhart-Harris, R. L. · Frontiers in Psychology (2018)

49 cited
Awe: a putative mechanism underlying the effects of classic psychedelic-assisted psychotherapy

Hendricks, P. S. · International Review of Psychiatry (2018)

143 cited
DMT models the near-death experience

Timmermann, C., Roseman, L., Williams, L. et al. · Frontiers in Psychology (2018)

Psychedelics as anti-inflammatory agents

Flanagan, T. W., Nichols, C. D. · International Review of Psychiatry (2018)

Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

Schenberg, E. E. · Frontiers in Pharmacology (2018)

DARK Classics in Chemical Neuroscience: Psilocybin

Geiger, H. A., Wurst, M. G., Daniels, R. N. · ACS Chemical Neuroscience (2018)

Effects of psilocybin therapy on personality structure

Erritzoe, D., Roseman, L., Nour, M. R. et al. · Acta Psychiatrica Scandinavica (2018)

219 cited
Psychological variables implied in the therapeutic effect of ayahuasca: A contextual approach

Franquesa, A., Sainz-Cort, A., Gandy, S. et al. · Psychiatry Research (2018)

47 cited
Dark Classics in Chemical Neuroscience: Mescaline

Cassels, B. K., Sáez-Briones, P. · ACS Chemical Neuroscience (2018)

Unifying theories of psychedelic drug effects

Swanson, L. R. · Frontiers in Pharmacology (2018)

Employing Synergistic Interactions of Virtual Reality and Psychedelics in Neuropsychopharmacology

Moroz, M., Carhart-Harris, R. L. · IEEE Explore (2018)

6 cited
Quality of acute psychedelic experience predicts therapeutic efficacy of psilocybin for treatment-resistant depression

Roseman, L., Nutt, D. J., Carhart-Harris, R. L. · Frontiers in Pharmacology (2018)

A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder

Barsuglia, J. P., Polanco, M., Palmer, R. et al. · Progress in Brain Research (2018)

Psychiatry & the psychedelic drugs. Past, present & future

Rucker, J., Iliff, J., Nutt, D. J. · Neuropharmacology (2017)

Psychedelic pleasures: An affective understanding of the joys of tripping

Bøhling, F. · International Journal of Drug Policy (2017)

Serotonin and brain function: a tale of two receptors

Carhart-Harris, R. L., Nutt, D. J. · Journal of Psychopharmacology (2017)

The therapeutic potential of psychedelic drugs: past, present, and future

Carhart-Harris, R. L., Goodwin, G. M. · Neuropsychopharmacology (2017)

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