Trial intelligence / Profile preview

Daridorexant in MDD With Insomnia

2025-524794-16-00Phase 4Authorised

Sponsor
Bellvitge Institute for Biomedical Research
Start
Oct 2026
Modality
Small Molecules
Countries
1
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Overview

Phase 4, randomised, double-blind trial in major depressive disorder (MDD) and Insomnia comparing Daridorexant with Placebo (2 arms). Primary endpoint: Insomnia Severity Index (ISI) score at 3 months. Planned start Oct 2026; status: authorised.

02

Drugs

daridorexant
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Conditions

major depressive disorder (MDD)Insomnia

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