DARIDOREXANT for Chronic insomnia disorder

Inclusion criteria

• {"criterion_text":"- 1.\tMale and female patients aged ≥18 years old and < 65 years old with a diagnosis of chronic insomnia disorder according to the ICSD-3;\n- 2.\tStarting daridorexant 50 mg daily according to the regulatory approved indication;\n- 3.\tPatients who are able and willing to give written informed consent, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply with the study requirements."}

Exclusion criteria

• {"criterion_text":"- 1.\tConcomitant sleep disorders\n- 2.\tMajor psychiatric disorders\n- 3.\tPatients contraindicated for daridorexant use (according to SmPC)\n- 4.\tDose adjustment of daridorexant or prescription to 25 mg/day\n- 5.\tPregnancy or planned pregnancy\n- 6.\tHistory of suicide ideations and/or attempts\n- 7.\tHistory of epilepsy\n- 8.\tPrevious cerebrovascular diseases\n- 9.\tHeavy smoking\n- 10.\tShift-work\n- 11.\tUse of drugs affecting cognition\n- 12.\tBody Mass Index >35"}

Primary endpoints

• {"endpoint_text":"- 1.\tChange in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits;","definition_or_measurement_approach":"Change in ISI total score measured at 3- and 6-month follow-up visits (patient-reported insomnia severity index)."}
• {"endpoint_text":"- 2.\tChange in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;","definition_or_measurement_approach":"Change in subjective total sleep time (sTST) measured by patient sleep diary during the 7 days before the 3- and 6-month visits."}

Secondary endpoints

• {"endpoint_text":"- Change in cogn perf (attention and memory) measured by neuropsychological tests at the 3and 6monthFUvisits;","definition_or_measurement_approach":"Cognitive performance in attention and memory domains measured by neuropsychological tests at 3- and 6-month follow-up visits."}
• {"endpoint_text":"- Change in PSQI total and sub-items scores at 3and 6monthFUvisits;","definition_or_measurement_approach":"Pittsburgh Sleep Quality Index (PSQI) total score and sub-item scores assessed at 3- and 6-month visits."}
• {"endpoint_text":"- Change in ESS scores at 3and 6monthFUvisits;","definition_or_measurement_approach":"Epworth Sleepiness Scale (ESS) scores assessed at 3- and 6-month visits."}
• {"endpoint_text":"- Change in MEQ scores at 3and 6monthFUvisits;","definition_or_measurement_approach":"Morningness-Eveningness Questionnaire (MEQ) scores assessed at 3- and 6-month visits."}
• {"endpoint_text":"- Change in Beck Depression Inventory-II total score at 3and 6monthFUvisits;","definition_or_measurement_approach":"Beck Depression Inventory-II total score assessed at 3- and 6-month visits to monitor depressive symptoms."}
• {"endpoint_text":"- Change in the mental and physical component of the SF-12 at 3and 6monthFUvisits.","definition_or_measurement_approach":"SF-12 health survey mental and physical component scores assessed at 3- and 6-month visits."}

Italy

Earliest CTIS Part Ii Submission Date

16-11-2024

Latest Decision Or Authorization Date

04-05-2025

Processing Time Days

169

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Universita' Degli Studi Di Roma Tor Vergata

Organisation Type

Educational Institution

Country Of Registered Address

Italy