Five serious adverse events – anxiety, delusion, delirium, suicidal ideation, and suicidal attempt – were judged by the investigator to be related to the esketamine.
Researchers also saw no declines in performance on multiple cognitive domains, including visual learning and memory, across the entire study.
“The adverse event profile following an up to 1 year of exposure was consistent with previous observations of esketamine in the completed short-term phase 2 and 3 studies, and no unexpected safety findings were reported,” wrote Ewa Wajs, MD, also with Janssen, and coauthors.
Both studies were funded by Janssen Research & Development. Of the authors in the first study, 12 were employees of Janssen, and 10 declared funding from the pharmaceutical industry, including Janssen. Of the authors in the second study, 11 were employees of Janssen, and four declared a range of funding from the pharmaceutical industry.
SOURCE: Daly EJ et al. ASCP 2018, Poster W68. Wajs E et al. ASCP 2018, Poster T67.