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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07555743
Lead Sponsor Institut d'Investigació Biomèdica de Bellvitge
Collaborators: Idorsia Pharmaceuticals Ltd., Hospital Universitari de Bellvitge
Conditions
(from sponsor)		 Insomnia, Major Depressive Disorder
Related terms Major Depressive Disorder, Sleep Initiation and Maintenance Disorders
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov