40% unreported adverse events in esketamine trials

  • SOURCE ▸
    PUBLISHED
  • April 26, 2023
  • AUTHORS
  • Tanguy Taillefer de Laportalière, Adeline Jullien, Antoine Yrondi
  • PUBLICATION
  • Psychological Medicine
  • TITLE
  • 40% unreported adverse events in esketamine trials
  • Reporting of harms in clinical trials of esketamine in depression: a systematic review
  • KEY TAKEAWAY
  • 40% of adverse events, including feelings of suicidality, in esketamine trials are unreported, highlighting the need for thorough reporting and monitoring in psychedelic substance use.

The systematic review by Taillefer de Laportalière et al. (2023) in "Psychological Medicine" presents critical findings on the reporting of harms in clinical trials of esketamine for treating depression, especially resistant depression. This study aimed to assess the quality of adverse event (AE) reporting across all published clinical trials concerning esketamine and compare the proportions of AEs reported in journal articles to those recorded in ClinicalTrial.gov Registers. Through a comprehensive search and quality assessment using a 21-item checklist from the CONSORT Extension of Harms, the review included ten clinical trials. Findings revealed a concerning scenario: nine out of these ten trials were categorized as 'low quality' regarding safety reporting, with one trial being 'moderate quality'. Alarmingly, compared to AEs recorded in ClinicalTrials.gov, it was found that 41.5% of serious AEs and 39% of non-serious AEs were not reported in the published articles. This underreporting predominantly involved psychiatric and cardiovascular events, with 94% affecting patients in esketamine groups.For the psychedelic harm reduction community and the broader public, these findings underscore a significant issue in the transparency and reliability of published data on esketamine's safety profile. The underreporting of serious and non-serious AEs, particularly those of a psychiatric nature, poses a challenge in accurately assessing the benefits/risks balance of esketamine, a concern for both healthcare providers and patients considering this treatment option. It suggests a need for more stringent requirements for harm reporting in clinical trials to ensure the safety and well-being of individuals exploring esketamine as a treatment for resistant depression. This review highlights the importance of looking beyond journal publications to comprehensive registries like ClinicalTrials.gov for a fuller understanding of a drug's safety profile, emphasizing the need for increased transparency and completeness in the reporting of harm data.This summary should serve as a call to action for improving harm reporting standards in clinical trials, particularly those exploring treatments within the realm of psychedelic medicine. Ensuring the safety and well-being of patients must remain paramount, with accurate and transparent reporting of all potential risks associated with these emerging therapies.(Taillefer de Laportalière et al., 2023)

Stay Informed

Research, news, and information about psychedelic safety.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.