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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
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).
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 757 |
| Start date | Tue Sep 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Depressive Disorder, Major
Interventions
- Seltorexant
- Matching placebo to Seltorexant
- Quetiapine XR
- Matching placebo to Quetiapine XR
Countries
Slovakia, Russia, Malaysia, Ukraine, Belgium, Serbia, United Kingdom, Poland, Argentina, Canada, Lithuania, Bulgaria, Latvia, United States, Czechia