Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials.

ABSTRACT:

Purpose

To evaluate the relationship of sleep disturbance to the antidepressant effects of esketamine.

Materials and methods

Two double-blind, 4-week studies randomized adults with treatment-resistant depression (TRD) to placebo or esketamine nasal spray, each with newly initiated antidepressant. Sleep was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS) item 4. Change in response (≥50% decrease in MADRS total score) and remission (total MADRS score ≤12) at day 28 was examined by presence/absence of baseline sleep disturbance using logistic regression models. Impact on reported sleep disturbance (MADRS item 4 score) was examined using ANCOVA models.

Results

At baseline, most patients reported disturbed sleep - moderate/severe (65.3%, 369/565), mild (25

SUBMITTER: Borentain S 

PROVIDER: S-EPMC8646953 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature