The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.