Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
This study tests whether a new medication called seltorexant, when added to an antidepressant, can help improve depression and sleep problems in adults and elderly patients. Researchers will compare seltorexant to a placebo (inactive pill) to see which works better and is safe to use.
Key Objective:The trial is testing whether seltorexant can reduce depression symptoms and improve sleep when added to existing antidepressant treatment.
Who to Consider:Adults and elderly patients with major depression and insomnia who are already taking an antidepressant but still experiencing symptoms should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: Participants in part 1 and direct enrollers to part 2: * Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60 * Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment * Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the particip