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

Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Study ID
NCT07555743
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 50 mg — DRUG
    oral taking of Daridorexant 50mg/daily at bedtime, within 30 minutes of going to bed and at least 8-9 hours before planned wake time. Treatment duration: 12 weeks (3 months).
  • Placebo — DRUG
    Orally, once daily at bedtime, within 30 minutes of going to bed and at least 8-9 hours before planned wake time.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daridorexant 50mg
    Oral taking of Daridorexant, 50 mg/day for 3 months
  • Placebo Comparator: Placebo
    Oral taking of placebo for 3 months

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: ISI will be administered to all patients at baseline, and at months 1 and 3. ]

Central Contacts

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