A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Summary

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 a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Timeline

Start

2020-09-15

Primary completion

2022-05-24

Completion

2022-07-14

Outcome

Missed primary endpoint

Stopped: “42847922MDD3002 was stopped based on the interim analysis (IA) results as recommended by the Independent Data Monitoring Committee (IDMC)”

registry analysis (superiority test); Seltorexant vs Placebo; p =0.411 NCT04532749 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seltorexant	Small molecule	20 mg	Oral

Indications