Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life
Por:
Goodwin GM, Aaronson ST, Alvarez O, Atli M, Bennett JC, Croal M, DeBattista C, Dunlop BW, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Lennard-Jones MR, Licht RW, Marwood L, Mistry S, Pálenícek T, Redjep O, Repantis D, Schoevers RA, Septimus B, Simmons HJ, Soares JC, Somers M, Stansfield SC, Stuart JR, Tadley HH, Thiara NK, Tsai J, Wahba M, Williams S, Winzer RI, Young AH, Young MB, Zisook S and Malievskaia E
Publicada:
14 abr 2023
Ahead of Print:
1 feb 2023
Resumen:
Background: COMP360 is a proprietary, synthetic formulation of psilocybin being developed for treatment-resistant depression (TRD), a burdensome, life-threatening illness with high global impact. Here, we expand upon the previous report of primary outcomes from a phase 2 study of COMP360 in individuals with TRD-the largest randomised controlled clinical trial of psilocybin-to discuss findings of the exploratory efficacy endpoints.Methods: In this phase 2, double-blind trial, 233 participants with TRD were randomised to receive a single dose of psilocybin 25 mg, 10 mg, or 1 mg (control), administered alongside psychological support from trained therapists. Efficacy measures assessed patient-reported depression severity, anxiety, positive and negative affect, functioning and associated disability, quality of life, and cognitive function. Results: At Week 3, psilocybin 25 mg, compared with 1 mg, was associated with greater improvements from Baseline total scores in all measures. The 10 mg dose produced smaller effects across these measures. Limitations: Interpretation of this trial is limited by the absence of an active comparator and the possibility of functional unblinding in participants who received a low dose of psilocybin. Conclusions: Three weeks after dosing, psilocybin 25 mg and, to a lesser degree, 10 mg improved measures of patient-reported depression severity, anxiety, affect, and functioning. These results extend the primary findings from the largest randomised clinical trial of psilocybin for TRD to examine other outcomes that are of importance to patients.
Filiaciones:
Goodwin GM:
COMPASS Pathfinder Ltd, London, UK
Aaronson ST:
The Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt, Baltimore, MD, USA
Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA
Alvarez O:
Parc Sanitari Sant Joan de Deu, Barcelona, Spain
Sant Joan de Déu Research Foundation, Barcelona, Spain
Atli M:
COMPASS Pathfinder Ltd, London, UK
Bennett JC:
COMPASS Pathfinder Ltd, London, UK
Croal M:
COMPASS Pathfinder Ltd, London, UK
DeBattista C:
Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA
Dunlop BW:
Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
Feifel D:
Kadima Neuropsychiatric Institute, La Jolla, CA, USA
Hellerstein DJ:
New York State Psychiatric Institute, New York, NY, USA
Department of Psychiatry, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA
Husain MI:
Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Canada
Department of Psychiatry, University of Toronto, Toronto, Canada
Kelly JR:
Department of Psychiatry, Trinity Centre for Health Sciences, Tallaght University Hospital, Dublin, Ireland
Lennard-Jones MR:
COMPASS Pathfinder Ltd, London, UK
Licht RW:
Department of Psychiatry, Aalborg University Hospital, Aalborg, Denmark
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
Marwood L:
COMPASS Pathfinder Ltd, London, UK
Mistry S:
COMPASS Pathfinder Ltd, London, UK
Pálenícek T:
The National Institute of Mental Health, Klecany, Czech Republic
Redjep O:
COMPASS Pathfinder Ltd, London, UK
Repantis D:
Department of Psychiatry and Neurosciences, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany
Schoevers RA:
Department of Psychiatry, University Medical Centre Groningen, Groningen, the Netherlands
Septimus B:
COMPASS Pathfinder Ltd, London, UK
Simmons HJ:
COMPASS Pathfinder Ltd, London, UK
Soares JC:
UTHealth Harris County Psychiatric Center, Houston, TX, USA
Department of Psychiatry and Behavioral Sciences, UTHealth Center of Excellence on Mood Disorders, UT Houston Medical School, Houston, TX, USA
Somers M:
Department of Psychiatry, University Medical Centre Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands
Stansfield SC:
COMPASS Pathfinder Ltd, London, UK
Stuart JR:
COMPASS Pathfinder Ltd, London, UK
Tadley HH:
COMPASS Pathfinder Ltd, London, UK
Thiara NK:
COMPASS Pathfinder Ltd, London, UK
Tsai J:
COMPASS Pathfinder Ltd, London, UK
Wahba M:
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, UK
Newcastle University, Newcastle upon Tyne, UK
Williams S:
COMPASS Pathfinder Ltd, London, UK
Winzer RI:
COMPASS Pathfinder Ltd, London, UK
Young AH:
Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, London, UK
Young MB:
COMPASS Pathfinder Ltd, London, UK
Zisook S:
Department of Psychiatry, University of California San Diego, San Diego, CA, USA
Malievskaia E:
COMPASS Pathfinder Ltd, London, UK
Green Submitted, gold
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