Esketamine nasal spray used with an oral antidepressant was significantly more effective at delaying a relapse of depression compared with placebo, based on data from 297 adults in remission.
Patients with treatment-resistant depression are more likely to relapse, wrote, of Janssen Research and Development, Titusville, N.J., and colleagues.
In the JAMA Psychiatry, the researchers randomized 297 adults in the maintenance phase of depression treatment to esketamine hydrochloride or placebo. The average age of the patients was 46 years, and 66% were female.study, published in
among the 176 patients who achieved stable remission. In addition, relapse occurred in 25.8% in the esketamine and antidepressant group and 57.6 in the antidepressant and placebo among the patients who achieved stable response.
The median duration esketamine use during the maintenance phase was 17.7 weeks among patients who achieved stable remission and 19.4 among those who achieved stable response.
The study was designed to include a 4-week screening and prospective observation phase, a 4-week open-label induction phase, a 12-week optimization phase, a maintenance phase, and a 2-week posttreatment follow-up phase.
The most common adverse events reported by esketamine patients were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness. Most of these effects were moderate; no cases of respiratory depression, interstitial cystitis, or death were reported.
The results were limited by several factors, including the transient effects of esketamine that made blinding difficult, the researchers noted. However, the findings support the safety of the spray and “significant, clinically meaningful superiority” of the spray, compared with placebo, for relapse prevention in patients with treatment-resistant depression, they concluded.
Janssen Research and Development funded the study. Dr. Daly and several coauthors are employees of the company.
SOURCE: Daly E et al. JAMA Psychiatry. 2019 Jun 5. .