drugset / Trial / NCT04513912

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

NCT04513912 ↗

Phase 3 Completed 757 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response 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
2023-10-03
Completion
2023-10-03

Outcome

Missed primary endpoint

release “Although the study did not meet its primary endpoint, seltorexant showed efficacy comparable to quetiapine XR, a medication with proven efficacy for MDD” jnj.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Quetiapine Small molecule — Oral
Subject Seltorexant Small molecule 20 mg Oral