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Study evaluating the efficacy and safety of daridorexant in patients with major depressive disorder and insomnia.
EU CTIS ID: 2025-524794-16-00
What this study is testing
To evaluate the efficacy of Daridorexant in improving insomnia assessed with the ISI in MDD patients at 3 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 ≥ 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.
You likely can't join 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).
- 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).
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.