A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms
A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Inclusion Criteria:
Participants in part 1 and direct enrollers to part 2:
Participants entering after completing part 1:
Exclusion Criteria:
Participate-In-This-Study1@its.jnj.com844-434-4210
Bryant, Arkansas 72022, United States
Buenos Aires, C1133AAH, Argentina
Criciúma, 88811 000, Brazil
Natal, 59012 300, Brazil
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Barranquilla, 080002, Colombia
San Luis de Potosi, 78218, Mexico
Bydgoszcz, 85 794, Poland
Bursa, 16285, Turkey (Türkiye)