Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life
Language English Country Netherlands Media print-electronic
Document type Randomized Controlled Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't
PubMed
36740140
DOI
10.1016/j.jad.2023.01.108
PII: S0165-0327(23)00126-X
Knihovny.cz E-resources
- Keywords
- Antidepressant, Anxiety, Patient-reported outcomes, Psilocybin, Psychedelic, Treatment-resistant depression,
- MeSH
- Depression MeSH
- Depressive Disorder, Major * MeSH
- Patient Reported Outcome Measures MeSH
- Quality of Life MeSH
- Humans MeSH
- Psilocybin * MeSH
- Anxiety MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Psilocybin * MeSH
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.
COMPASS Pathfinder Ltd London UK
Department of Psychiatry and Behavioral Sciences Emory University School of Medicine Atlanta GA USA
Department of Psychiatry and Behavioral Sciences Stanford University Stanford CA USA
Department of Psychiatry University Medical Centre Groningen Groningen the Netherlands
Department of Psychiatry University of California San Diego San Diego CA USA
Kadima Neuropsychiatric Institute La Jolla CA USA
Parc Sanitari Sant Joan de Déu Barcelona Spain; Sant Joan de Déu Research Foundation Barcelona Spain
The National Institute of Mental Health Klecany Czech Republic
References provided by Crossref.org
Serotonergic Psychedelics Rapidly Modulate Evoked Glutamate Release in Cultured Cortical Neurons
