2025-524794-16-00RecruitingPhase 4
Efficacy and Safety of Daridorexant in Patients with Major Depressive Disorder (MDD) and Insomnia: Double-blind, randomized, controlled trial
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL3 sites in 1 country134 target enrollmentStarted: January 15, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 134
- Locations
- 3
- Primary Endpoint
- Improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) at 3 months.
Study Overview
Brief Summary
To evaluate the efficacy of Daridorexant in improving insomnia assessed with the ISI in MDD patients at 3 months.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥ 20 on the Montgomery–Åsberg Depression Rating Scale (MADRS).
- •Insomnia disorder confirmed according to DSM-5
- •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.
Exclusion Criteria
- •Other Current Psychiatric Disorders: Any current psychiatric disorder other than major depressive disorder (e.g., active psychotic disorders, mania, hypomania, acute schizophrenia, schizoaffective disorder).
- •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 (i.e., >4 standard drinks/day for men, >2 standard drinks/day for women).
- •Use of Non-Permitted Sleep Medications: Concurrent use of melatonin, benzodiazepines, sedative antidepressants or sedative antipsychotics use for insomnia not allowed by the protocol and unwillingness to follow the slow-taper schedule constitutes an exclusion criterion.
- •No concurrent sleep medications at least 30 days prior to baseline. Exclusion criteria if the patient has withdrawal symptoms and/or sleep disturbances measured by BWSQ prior to baseline.
- •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.
Arms & Interventions
CELLULOSE, MICROCRYSTALLINE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, CROSCARMELLOSE SODIUM
Placebo
Intervention: CROSCARMELLOSE SODIUM (Drug)
CELLULOSE, MICROCRYSTALLINE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, CROSCARMELLOSE SODIUM
Placebo
Intervention: COLLOIDAL SILICON DIOXIDE (Drug)
CELLULOSE, MICROCRYSTALLINE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, CROSCARMELLOSE SODIUM
Placebo
Intervention: MAGNESIUM STEARATE (Drug)
CELLULOSE, MICROCRYSTALLINE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, CROSCARMELLOSE SODIUM
Placebo
Intervention: CELLULOSE, MICROCRYSTALLINE (Drug)
DARIDOREXANT
Test
Intervention: DARIDOREXANT (Drug)
Outcomes
Primary Outcomes
Improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) at 3 months.
Improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) at 3 months.
Secondary Outcomes
- To evaluate the efficacy of Daridorexant compared with placebo in improving insomnia as measured by overnight polysomnography at 3 months, including sleep latency, total sleep time, wake after sleep onset.
- To evaluate the efficacy of Daridorexant compared with placebo in improving depressive symptoms in patients with Major Depressive Disorder (MDD) at 3 months, measured by Montgomery–Åsberg Depression Rating Scale (MADRS), MINI Suicide Module.
- To evaluate the safety of Daridorexant compared with placebo by monitoring worsening of depressive symptoms, emergence of suicidal ideation at baseline and at 3 months.
- To compare the side-effect profile of Daridorexant with placebo over the 3-month treatment period.
- To evaluate the efficacy of Daridorexant compared with placebo in improving quality of life, measured by the EuroQol (EQ-5D) after insomnia treatment at 3 months.
Investigators
UICEC
Scientific
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Study Sites (3)
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