In a recent phase 3, multicenter, double-blind, randomized withdrawal study, esketamine nasal spray plus an oral antidepressant was compared to an oral anti-depressant plus placebo nasal spray for treatment-resistant depression (TRD). The study was conducted from October 2015 to February 2018 and consisted of 455 patients with TRD. During the 16-week optimization phase, patients received esketamine nasal spray (56 or 84 mg) plus an oral antidepressant. After the optimization phase, 297 patients who achieved stable remission or stable response were randomized (1:1) to either receive esketamine nasal spray or placebo nasal spray while continuing to take anti-depressants. Among those (n=176) who achieved stable remission, 24 (26.7%) in the esketamine and antidepressant group and 39 (45.3%) in the antidepressant and placebo group experienced relapse (log-rank P = 0.003, number needed to treat [NNT, 6]. Among those who achieved a stable response, 16 (25.8%) in the esketamine and antidepressant group and 34 (57.6%) in the antidepressant and placebo group experienced relapse (log-rank P < 0.001, NNT, 4). Esketamine and antidepressant treatment decreased the risk of relapse by 51% (hazard ratio [HR], 0.49; 95% CI, 0.29-0.84) among patients who achieved stable remission and 70% (HR, 0.30; 95% CI, 0.16-0.55) among those who achieved stable response compared with placebo and antidepressant treatment. These results are the first to be reported from a controlled maintenance study on the evaluation of whether esketamine nasal spray plus an oral antidepressant can sustain antidepressant effects in patients with TRD to a greater extent than an oral antidepressants alone.
Reference:
Daly EJ, et al. JAMA Psychiatry 2019; doi: 10.1001/jamapsychiatry.2019.1189. Epub ahead of print. Abstract
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