When used with an oral antidepressant, the occurrence of mild-to-moderate adverse effects of esketamine nasal spray decreased over time.
Putting It Into Practice
Approximately one-third of patients with major depressive disorder do not respond to > 2 oral antidepressants.
The S-enantiomer of racemic ketamine has been shown to have a greater affinity for the N-methyl-D-aspartate receptor than the R-enantiomer, thus has a rapid onset (within hours) and durable efficacy.
Patients with treatment-resistant depression who are treated with esketamine nasal spray plus a new oral antidepressant have a decreased symptom burden, and improved functional ability and health-related quality of life.
Why this study matters
Esketamine nasal spray plus a new oral antidepressant is effective and well-tolerated among patients with treatment-resistant depression.
Data were derived from 2 long-term phase 3 trials involving patients with treatment-resistant major depressive disorder who had not responded to > 2 oral antidepressant medications.
The trial participants were treated with a new oral antidepressant plus esketamine nasal spray (56 or 84 mg biw) during the 4-week induction phase, then weekly x 5 w, and weekly or qow during maintenance. The incidence, frequency, and severity of adverse events were the outcomes of interest in the post hoc analysis.
Results and conclusion
Nine hundred twenty-eight patients with treatment-resistant depression were enrolled in the trials.
The following symptoms and incidences occurred after the 1st week of treatment: dizziness, 20.6%; nausea, 14.0%; vertigo, 12.1%; increased blood pressure, 4.3%; and sedation, 3.8%.
Williamson DJ, Gogate JP, Sliwa JKK, et al. Longitudinal course of adverse events with esketamine nasal spray: A post hoc analysis of pooled data from phase 3 trials in patients with treatment-resistant depression. Journal of Clinical Psychiatry 2022;published online ahead of print.