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
Qualifiers
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
Treatments tested in this trial
- Daridorexant 50 mg
- Placebo
Treatment groups
134 Participants
are divided into 2 treatment groupsSponsors and collaborators
Institut d'Investigació Biomèdica de Bellvitge
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Collaborator
Hospital Universitari de Bellvitge
Collaborator
Source ClinicalTrials.gov