Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorInstitut d'Investigació Biomèdica de Bellvitge
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other Current Psychiatric Disorders: Any current psychiatric disorder other than major depressive disorder (e.g., active psychotic disorders, mania, hypomania, acute schizophrenia, schizoaffective disorder).
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Daridorexant 50 mg
Drugoral 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).
Placebo
DrugOrally, once daily at bedtime, within 30 minutes of going to bed and at least 8-9 hours before planned wake time.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Daridorexant 50mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
ISI will be administered to all patients at baseline, and at months 1 and 3.Secondary outcomes
1
Sleep Efficiency (polysomnography)
•Sleep Efficiency (%): Total Sleep Time (minutes) / time in bed (minutes).
Time frame
Polysomnography will be performed at baseline and at month 3.2
Total Sleep Time (Polysomnography)
Total Sleep Time (TST): measured in minutes.
Time frame
PSG will be performed at baseline and at month 3.3
Wake After Sleep Onset (polysomnography)
Total number of minutes that a patient is awake after having initially fallen asleep.
Time frame
Polysomnography will be performed at baseline and at month 3.4
Arousal Index (polysomnography)
Number of arousals per hour of sleep.
Time frame
Polysomnography will be performed at baseline and at month 3.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut d'Investigació Biomèdica de Bellvitge
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Collaborator
Hospital Universitari de Bellvitge
Collaborator
Source ClinicalTrials.gov
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