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

NCT07555743 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Daridorexant 50 mg

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).

DRUG

Placebo

Orally, once daily at bedtime, within 30 minutes of going to bed and at least 8-9 hours before planned wake time.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Bellvitge

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2028-10-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555743 on ClinicalTrials.gov