![]() Seltorexant affected core symptoms of depression in the absence of overt changes in the hypnogram in contrast, diphenhydramine was not efficacious. Treatment with seltorexant was associated with mild, self-limiting adverse drug reactions. Compared to placebo, the antidepressant efficacy of seltorexant coincided with an overall increase in (left posterior) EEG power and a relative increase in delta- and decrease in theta-, alpha- and beta power during stage 2 sleep. Ten days of treatment with seltorexant (and not diphenhydramine) resulted in a significant improvement of core depressive symptoms compared to placebo the antidepressant efficacy of seltorexant was maintained with continued treatment up to 28 days. At baseline the severity of depressive symptoms correlated with sleep efficiency (SE), wake after sleep onset (WASO), duration of stage 2 sleep, and ruminations. To investigate the safety and tolerability of seltorexant, vital signs, suicidal ideation and adverse events were monitored. Effects on sleep were evaluated by polysomnography and by the Leeds Sleep Evaluation Questionnaire (LSEQ). Symptoms of depression were rated using the 17-item Hamilton Depression Rating Scale (HDRS 17). 47 MDD patients with a total Inventory of Depressive Symptomatology (IDS) score of ≥30 at screening were included in a randomized, double-blind, diphenhydramine-, and placebo-controlled multicentre study. In this study, the effects of night-time arousal suppression on depressive symptoms were investigated. ![]() ![]() Seltorexant (JNJ-42847922/MIN-202) is a selective antagonist of the human orexin-2 receptor (OX2R) that may normalize excessive arousal and thereby attenuate depressive symptoms. Excessive arousal has a role in the pathophysiology of major depressive disorder (MDD). ![]()
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