Long-Term Esketamine Could Improve Depression Outcomes

Long-term use of esketamine nasal spray plus antidepressant can help to delay relapse in patients with treatment-resistant depression (TRD), according to the results of a recent study.

Previous studies have shown that short-term use of esketamine is effective for improving outcomes in patients with TRD, but little is known about its effectiveness in the long-term.

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The researchers conducted a phase 3, multicenter, double-blind randomized withdrawal study involving 705 adults with TRD, 455 of whom entered the optimization phase and were treated with esketamine nasal spray (56 or 84 mg) plus oral antidepressant.

After 16 weeks, 297 patients had achieved stable remission or stable response and were entered into the randomization withdrawal phase, in which they were randomly assigned (1:1) to continue esketamine or switch to placebo.

Overall, 176 of the 297 patients who entered the randomized maintenance phase achieved stable remission and 24 (26.7%) in the esketamine group and 39 (45.3%) in the placebo group experienced relapse. Among 121 who achieved stable response, 16 (25.8%) in the esketamine group and 34 (57.6%) in the placebo group experienced relapse.

The most common adverse events related to esketamine use were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness.

“This study demonstrated that, after 16 weeks of initial treatment, continued treatment with esketamine plus antidepressant leads to significant, clinically meaningful superiority compared with an antidepressant plus placebo for relapse prevention among patients with TRD and provides further safety data supporting a positive benefit-risk ratio of long-term treatment.”

—Michael Potts

Reference:

Daly EJ, Trivedi MH, Janik A, et al. Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression [published online June 5, 2019]. JAMA Psychiatry. doi:10.1001/jamapsychiatry.2019.1189