Tests daridorexant in adults with depression and insomnia
Tests daridorexant against a placebo in adults with depression and insomnia.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia
Key facts
- Where
- Barcelona, SpainSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07555743, who can take part
Where in Spain
- Hospital Universitari de BellvitgeBarcelona, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut d'Investigació Biomèdica de Bellvitge
- Trial code
- NCT07555743
- Record updated
- 29 April 2026
- Original description
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:Read full original descriptionShow less
Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder (MDD) and Insomnia: Double-blind, Randomized, Controlled Trial
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.
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; 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.
Exclusion: 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; Concomitant Use with Moderate and potent CYP3A4 Inhibitors: Prohibited due to potential drug interaction (refer to protocol section 4.5 for specifics); 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); 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; 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; Pregnancy or breastfeeding; Cognitive Impairments: Significant impairments that prevent the comprehension or completion of study questionnaires or procedures; 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 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.