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

NCT07555743 | Not Yet Recruiting Phase 4

• 1 other identifier: SEDA
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Insomnia; Major Depressive Disorder

Keywords

Daridorexant; Clinical Trial; Insomnia; Major depressive disorder; Polysomnography; Insomnia Severity Index

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  The Insomnia Severity Index is a widely used, self-reported questionnaire designed to assess the nature, severity, and impact of insomnia symptoms. Each item is rated on a 5-point Likert scale from 0 to 4. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. According to the results insomnia will be classified as follows: 0-7: absence of clinical insomnia; 8-14: subclinical insomnia; 15-21: clinical insomnia; 22-28: severe insomnia.

  ISI will be administered to all patients at baseline, and at months 1 and 3.

Secondary Outcomes (18)

• Sleep Efficiency (polysomnography)

  Polysomnography will be performed at baseline and at month 3.

• Total Sleep Time (Polysomnography)

  PSG will be performed at baseline and at month 3.

• Wake After Sleep Onset (polysomnography)

  Polysomnography will be performed at baseline and at month 3.

• Arousal Index (polysomnography)

  Polysomnography will be performed at baseline and at month 3.

• Cumulative time spent under 90% oxygen saturation (polysomnography)

  Polysomnography will be performed at baseline and at month 3.

Study Arms (2)

Daridorexant 50mg

EXPERIMENTAL

Oral taking of Daridorexant, 50 mg/day for 3 months

Drug: Daridorexant 50 mg

Placebo

PLACEBO COMPARATOR

Oral taking of placebo for 3 months

Drug: Placebo

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).

Daridorexant 50mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age Range: 18-99 years old.
• Patients with a current major depressive episode according to DSM-5, in a stable phase (defined as at least 4 weeks without significant changes in antidepressant treatment and no psychiatric hospitalizations in the previous 8 weeks) and with moderate or greater severity, as indicated by a total score of
• on the Montgomery-Åsberg Depression Rating Scale (MADRS).
• Insomnia disorder confirmed according to DSM-5
• Insomnia Severity: Insomnia Severity Index (ISI) score = o \>15.
• Medication Stability defined by :
• Stable doses of antidepressants, mood stabilizers, or antipsychotics for at least 1 month prior to baseline (T0).
• Melatonin, Benzodiacepines, sedative antidepressants or sedative antipsychotics use for insomnia should follow a wash out protocol described below.
• Informed Consent: Ability and willingness to provide written informed consent.
• Acceptance of Protocol Requirements: Agreement to adhere to all scheduled visits, treatment plans, and study procedures.

You may not qualify if:

• Other Current Psychiatric Disorders: Any current psychiatric disorder other than major depressive disorder (e.g., active psychotic disorders, mania, hypomania, acute schizophrenia, schizoaffective disorder).
• Uncontrolled Severe Medical Conditions: Any condition that could interfere with study procedures, safety, or outcome measures (e.g., unstable cardiovascular, respiratory, neurological, or endocrine disorders).
• Pregnancy or breastfeeding
• Cognitive Impairments: Significant impairments that prevent the comprehension or completion of study questionnaires or procedures.
• Hypersensitivity: Known allergy or hypersensitivity to daridorexant or any of its excipients.
• Specific Sleep Disorders: Sleep apnea or hypopnea index ≥ 15 events/hour (based on American Academy of Sleep Medicine criteria) or any event associated with oxygen saturation \< 80% (as measured by polysomnography).
• Periodic limb movement index ≥ 15 events/hour (as measured by polysomnography). Restless legs syndrome, circadian rhythm sleep-wake disorders, REM behavior disorder, or narcolepsy.
• Concomitant Use with Moderate and potent CYP3A4 Inhibitors: Prohibited due to potential drug interaction (refer to protocol section 4.5 for specifics).
• Moderate and severe hepatic Impairment: Any hepatic condition deemed unsafe for daridorexant use.
• Relapse or Worsening of the Main Diagnosis: Relapse of depression whose severity precludes continued participation according to the investigator's judgment.
• Substance Use Disorder: History of substance use disorder without sustained remission. Exception: past sedative abuse may be permissible if remission criteria are clearly met, as determined by the investigator.
• Excessive Caffeine Intake: Daily consumption of \>400 mg of caffeine (e.g., \>4 standard cups of coffee).
• High-Risk Alcohol Consumption: Alcohol intake above recommended risk thresholds in accordance with the guidelines of the Spanish Ministry of Health: i.e., \>4 standard drinks/day (\>40g/d) for men, \>2 standard drinks/day (\>20g/d) for women.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Idorsia Pharmaceuticals Ltd.: collaborator
• Hospital Universitari de Bellvitge: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

Barcelona, Catalonia, 08908, Spain

Location

Related Publications (22)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders

Central Study Contacts

Sara Lakis Granell, MD

CONTACT

+34 932 60 79 22; slakis@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)