A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy and an Open-labeled Long-term Safety Extension Treatment With Seltorexant
Abstract
The purpose of this study is to assess the efficacy of seltorexant compared with placebo as 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 an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.
Conditions: Depressive Disorder, Major.
Primary outcome: Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1; Open Label (OL) Treatment Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs); OL Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI); OL Treatment Phase: Change From Baseline in Vital Signs: Blood Pressure; OL Treatment Phase: Change From Baseline: Body Mass Index (BMI); OL Treatment Phase: Change From Baseline in Vital Signs: Temperature; OL Treatment Phase: Change From Baseline in Vital Signs: Pulse Rate; OL Treatment Phase: Change From Baseline in Weight; OL Treatment Phase: Change From Baseline in Waist Circumference; OL Treatment Phase: Number of Participants…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 588 participants or records.
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