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Esketamine Shows Antidepressant Efficacy Regardless of Sleep Disturbance in Treatment-Resistant Depression
Esketamine nasal spray initiated with an antidepressant outperformed placebo, also initiated with an antidepressant, in easing treatment-resistant depression regardless of the presence of sleep disturbance and in improving sleep after 8 days of treatment, according to an exploratory study published in Neuropsychiatric Disease and Treatment.
“The impact that sleep disturbance has on depression, and vice versa, underscores the need for optimal treatment of both. Depression accompanied by sleep disturbance are oftentimes simultaneously treated, with one or both too frequently inadequately treated,” wrote researchers from Janssen Research & Development and Augusta University Medical College of Georgia.
To investigate the relationship between sleep disturbance and the antidepressant effects of esketamine, researchers conducted post-hoc analyses of pooled data from a pair of 4-week, double-blind, randomized controlled trials: TRANSFORM-1 and TRANSFORM-2. The study included a total 565 adults with treatment-resistant depression who received placebo or esketamine nasal spray, each with newly initiated open-label antidepressant.
At baseline, 65.3% of participants reported disturbed sleep that was moderate or severe, and 25.3% reported mildly disturbed sleep.
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Compared with placebo plus antidepressant, the odds ratio for clinical response—defined as a 50% or greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) total score—was 2.05 for patients treated with esketamine plus antidepressant at 4 weeks, regardless of presence and severity of sleep disturbance, according to the study. The odds ratio for depression remission—defined as total MADRS score of 12 or less—was 1.81 for esketamine.
Sleep disturbance, as measured by MADRS item 4 score, improved in both groups after treatment started. Improvement was greater with esketamine, however, by day 8 and stayed that way through the end of the trials, the study found. A 1-point improvement in sleep by day 8 increased the likelihood of antidepressant response by 26%, and remission by 28%, on day 28 in both patient groups.
“Exploratory, post-hoc analyses support the antidepressant efficacy of esketamine nasal spray in patients with treatment-resistant depression, regardless of the presence or absence of sleep disturbance,” researchers wrote. “One week after the initiation of treatment, more esketamine-treated patients reported clinically meaningful improvement in sleep than those taking oral antidepressant plus placebo. Additional research, using objective markers of sleep and established clinical assessment tools of insomnia, will expand upon these findings.”
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