Study evaluating the efficacy and safety of daridorexant in patients with major depressive disorder and insomnia.

Trial details

Who runs it

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Trial code

EU 2025-524794-16-00

Record updated

2026. május 4.

Original description

To evaluate the efficacy of Daridorexant in improving insomnia assessed with the ISI in MDD patients at 3 months.Read full original descriptionShow less

Efficacy and Safety of Daridorexant in Patients with Major Depressive Disorder (MDD) and Insomnia: Double-blind, randomized, controlled trial

To evaluate the efficacy of Daridorexant in improving insomnia assessed with the ISI in MDD patients at 3 months.

Inclusion: 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: Concomitant Use with Moderate and potent CYP3A4 Inhibitors: Prohibited due to potential drug interaction (refer to protocol section 4.5 for specifics); 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; Other Current Psychiatric Disorders: Any current psychiatric disorder other than major depressive disorder (e.g., active psychotic disorders, mania, hypomania, acute schizophrenia, schizoaffective disorder); Moderate and severe hepatic Impairment: Any hepatic condition deemed unsafe for daridorexant use; 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; 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); 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; Relapse or Worsening of the Main Diagnosis: Relapse of depression whose severity precludes continued participation according to the investigator’s judgment; 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); Pregnancy or breastfeeding; Cognitive Impairments: Significant impairments that prevent the comprehension or completion of study questionnaires or procedures.

EU CTIS 2025-524794-16-00