Retrospective, non-interventional multicenter study on the effect of QUVIVIQ in patients with insomnia disorder with comorbid anxiety and/or depression disorders

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Retrospective study to collect existing data from patients with insomnia disorder and comorbid anxiety and/or depression disorders who are already treated with QUVIVIQ in psychiatric, sleep or neurological centres as part of their routine standard of care
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective data collection.

Study drug and medical condition

• Name of medicine:
  QUVIVIQ
• Study drug International non-proprietary name (INN) or common name:
  DARIDOREXANT HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (N05CJ03) daridorexant

  daridorexant
• Medical condition to be studied:
  Insomnia

  Anxiety disorder

  Depression

  Mixed anxiety and depressive disorder

Population studied

• Short description of the study population:
  The participants have been diagnosed with insomnia disorder and comorbid anxiety and/or depression. This patient population is routinely seen in participating psychiatric, neurological or sleep centres in the countries where the study will be conducted.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  220

Study design details

• Study design:
  Study design: multi-centre, retrospective, non-interventional study with no control group. ; Data collection: existing patient data found in medical records. ; Participants: patients who have received QUVIVIQ for at least 4 weeks for insomnia disorder with comorbid anxiety and/or depression.
• Main study objective:
  The main objective of the study is to describe the effects of QUVIVIQ in patients with insomnia disorder and comorbid anxiety and/or depression disorders, as follows: ; • The safety of QUVIVIQ in patients with insomnia disorder and comorbid anxiety and/or depression in a real world setting. ; • The efficacy of QUVIVIQ in treating insomnia in patients with insomnia disorder and comorbid anxiety and/or depression in a real-world setting. ; • The effect of QUVIVIQ on comorbid anxiety and/or depression in patients with insomnia disorder in a real world setting.
• Setting:
  Study periods ; (1) Baseline period: 15-week time-period prior to the date QUVIVIQ was first prescribed to a patient.; (2) QUVIVIQ prescription date: The date that QUVIVIQ was first prescribed to the patient.; (3) Observation period: The period from when QUVIVIQ was first prescribed to the patient up until signature of the informed consent form (ICF), allowing retrospective data collection. ; ; Patient population; • Aged ≥ 18 years at the start of treatment with QUVIVIQ.; • Diagnosed with insomnia disorder, characterised by difficulty initiating and/or maintaining sleep, occurring 3 or more nights per week for at least 3 months with daytime symptoms.; • Diagnosed with comorbid anxiety and/or depression.; • Prescribed QUVIVIQ and treated for at least 4 weeks.; • Clinically assessed while treated with QUVIVIQ at least once between 4 and 15 weeks after first prescription of QUVIVIQ.
• Outcomes:
  Only variables already recorded in the patient’s medical records will be collected. ; ; Endpoint definitions ; For all patients; • All adverse events, including any events of special interest (suicidal ideation, sleep paralysis and hallucinations, and somnolence) occurring during the baseline period and/or observation period.; • Change in Insomnia Severity Index© score from baseline to the last clinical on-treatment assessment between 4 and 15 weeks after first prescription of QUVIVIQ.; ; For patients diagnosed with comorbid anxiety; • Change in Self-Reported Anxiety Scale score or any local anxiety scale score from baseline to the last clinical on-treatment assessment between 4 and 15 weeks after first prescription of QUVIVIQ.; ; For patients diagnosed with comorbid depression; • Change in Beck Depression Inventory-II or any local depression scale score from baseline to the last clinical on-treatment assessment between 4 and 15 weeks after first prescription of QUVIVIQ.;
• Data analysis plan:
  Full analysis set: all participants for whom informed consent was obtained and who received QUVIVIQ for at least 4 weeks. ; ; Analysis of Self-Reported Anxiety Scale (SAS) scores: only patients diagnosed with comorbid anxiety. ; ; Analysis of Beck Depression Inventory-II (BDI-II) scores: only patients diagnosed with comorbid depression.; ; Subgroup analyses: participants with insomnia disorder and: (1) comorbid anxiety only, (2) comorbid depression only, (3) comorbid anxiety and depression. ; ; Change from baseline in Insomnia Severity Index©-, BDI-II- and SAS scores: one-sample t-test (95% confidence intervals for the mean change). ; ; Adverse events (AEs): number and percentage of patients experiencing any AE and each AE of interest during the pre-treatment period (i.e., AE ongoing at first prescription date of QUVIVIQ) and on-treatment period. The same AE summaries will be generated for the subgroup of patients diagnosed with comorbid anxiety, and for the subgroup of patients diagnosed with comorbid depression.