Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia

The goal of this clinical trial is to evaluate the efficacy and safety of Daridorexant in major depressive disorder (MDD) patients with comorbid insomnia. The main questions to answer are: 1. Does Daridorexant improve the severity of insomnia as measured by the Insomnia Severity Index (ISI)? 2. Does Daridorexant have an impact on depressive symptoms? In order to address these questions, researchers will compare Daridorexant with a placebo to evaluate its impact on both insomnia and MDD-related symptoms. Participants will: * Receive Daridorexant or placebo for a duration of three months * Complete a Sleep Diary and other questionnaires assessing sleep and depressive symptoms. * Undergo polysomnography to obtain objective measurements of sleep parameters.

NCT Number	NCT07555743
Lead Sponsor	Institut d'Investigació Biomèdica de Bellvitge Collaborators: Idorsia Pharmaceuticals Ltd., Hospital Universitari de Bellvitge
Conditions	Insomnia, Major Depressive Disorder
Enrollment	134 participants
Start Date	2026-04
Primary Completion	2027-04 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-29