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Seltorexant 20 mg as adjunctive therapy in major depressive disorder with insomnia
2023-509070-36-00Phase 3Authorised
- Sponsor
- Janssen Pharmaceutical
- Start
- Mar 2025
- Modality
- Small Molecules
- Countries
- 16
01
Overview
Phase 3, randomised, double-blind trial in major depressive disorder (MDD) and Insomnia comparing Seltorexant 20 mg adjunctive to SSRI/SNRI with Placebo adjunctive to SSRI/SNRI (2 arms). Primary endpoints: Change in MADRS total score at Day 43 (Part 1) and Time to first relapse during double-blind maintenance (Part 2). Planned start Mar 2025; status: authorised.
02
Drugs
seltorexant
03
Conditions
major depressive disorder (MDD)Insomnia
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