Patients with insomnia disorder comorbid with major depressive or anxiety disorder insomnia
Conditions
Interventions
After obtaining informed consent, during the observation period of sleep status prior to administration (Visit 1 to Visit 2), changes in insomnia treatment medications will be restricted, and baseline
Wearable Devices
Sponsors
Nakata Maiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria for Visit 1 1)Patients who can provide written informed consent to participate in this study of their own free will. 2)Male and female patients aged 18 years or older and under 65 years at the time of consent. 3)Patients diagnosed with insomnia disorder. 4)Patients with an Insomnia Severity Index (ISI) score between 8 and 21 at Visit 1 (indicating mild to moderate insomnia symptoms). 5)If receiving treatment for insomnia at Visit 1, patients must be able to continue the same treatment (type and dosage of insomnia medication) without changes until Visit 2. 6)(Cohort A: Comorbid Major Depressive Disorder Only) Patients diagnosed with major depressive disorder and presenting with mild to moderate depressive symptoms (PHQ-9 score between 5 and 19 at Visit 1). 7)(Cohort B: Comorbid Anxiety Disorder Only) Patients diagnosed with anxiety disorder and presenting with mild to moderate anxiety symptoms (GAD-7 score between 5 and 14 at Visit 1). 8)Patients who habitually go to bed between 21:00 and 01:00. 9)Patients who are able to fill out a sleep diary every morning and wear a wearable device every night during the study period. 10)Patients who are able to comply with the requirements of the study protocol. Criteria for Visit 2 1)Patients with an Insomnia Severity Index (ISI) score between 8 and 21 at Visit 2. 2)(Cohort A: Comorbid Major Depressive Disorder Only) Patients with a Patient Health Questionnaire-9 (PHQ-9) score between 5 and 19 at Visit 2. 3)(Cohort B: Comorbid Anxiety Disorder Only) Patients with a Generalized Anxiety Disorder-7 (GAD-7) score between 5 and 14 at Visit 2.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Visit 1 1)Patients who fall under off-label use of daridorexant, or those who are contraindicated, or those requiring special precautions due to specific background factors. 2)Patients diagnosed with both major depressive disorder and anxiety disorder at Visit 1. 3)Patients with a history or comorbidity of the following sleep disorders: Sleep apnea syndrome (obstructive or central) Periodic limb movement disorder Restless legs syndrome Circadian rhythm sleep-wake disorders REM sleep behavior disorder Narcolepsy 4)Patients with comorbid bipolar disorder. 5)Patients with conditions that may affect safety or study outcomes, including: Chronic pain [pain-related disorders] Malignant tumors 6)Patients taking daridorexant at Visit 1. 7)Patients who previously discontinued daridorexant due to insufficient efficacy or tolerability issues. 8)Patients using three or more insomnia medications at Visit 1 (including as-needed use). 9)Patients using two insomnia medications at Visit 1 who cannot discontinue one by Visit 2. 10)Patients taking orexin receptor antagonists (same mechanism as daridorexant) at Visit 1 who cannot discontinue by Visit 2. 11)Patients diagnosed with alcohol dependence within the past 2 years or unable to abstain from alcohol for more than 2 consecutive days. 12)Patients who cannot agree to abstain from supplements affecting sleep (e.g., melatonin, tryptophan, serotonin, glycine, chromium) from Visit 1 to Visit 6. 13)Patients unable to refrain from smoking from 2 hours before bedtime until waking. 14)Patients with a history of suicide attempts, self-harm, or drug overdose, or judged to have suicidal ideation at Visit 1. 15)Patients who changed dosage or administration of psychotropic drugs (e.g., antidepressants, anxiolytics) for major depressive disorder or anxiety disorder within 4 weeks before Visit 1 (excluding as-needed use). 16)Patients diagnosed with acute or unstable psychiatric disorders within 4 weeks before Visit 1. 17)Patients with a total sleep time (from bedtime to wake time) of less than 6 hours. 18)Patients who work night shifts or operate dangerous machinery such as driving vehicles as part of their job, or those who may potentially engage in such activities. 19)Patients who traveled internationally across >=4 time zones within 2 weeks before Visit 1 or plan to do so before Visit 4. 20)Patients deemed unsuitable for study participation by the investigator. Exclusion Criteria for Visit 2 1)Patients who had changes in dosage or administration of insomnia medications, psychotropic drugs (e.g., antidepressants, anxiolytics) for major depressive disorder or anxiety disorder between Visit 1 and Visit 2. 2)Patients taking two insomnia medications at Visit 1 who cannot discontinue either medication by Visit 2. 3)Patients taking insomnia medications with the same mechanism of action as daridorexant (orexin receptor antagonists) at Visit 1 who cannot discontinue them by Visit 2. 4)Patients with fewer than three days of sleep diary entries or wearable device records during the pre-treatment sleep observation period. 5)Patients who had three or more days during the pre-treatment sleep observation period in which they took naps longer than one hour, as recorded in the sleep diary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A:Change in total ISI score from Visit 2 to Visit 4 in patients with insomnia disorder comorbid with major depressive disorder Cohort B:Change in total ISI score from Visit 2 to Visit 4 in patients with insomnia disorder comorbid with anxiety disorder | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in total ISI score from Visit 2 to Visits 3, 5, and 6. -Change in individual ISI item scores from Visit 2 to Visits 3, 4, 5, and 6. -Changes in subjective total sleep time (sTST), subjective sleep latency (sLSO), subjective wake after sleep onset (sWASO), and subjective sleep efficiency (sSE) from Visit 2 to Visit 3, 4, 5, and 6. -PGI-I scores at Visits 3, 4, 5, and 6. -CGI-I scores at Visits 3, 4, 5, and 6. -Proportion of patients continuing treatment at Visits 3, 4, 5, and 6 relative to the total number of enrolled cases. -Change in total QOL-I score from Visit 2 to Visits 4, 5, and 6. -Change in WPAI scores (work productivity assessment) from Visit 2 to Visits 3, 4, 5, and 6. -Subjective Sleep Refreshment:Change in perceived sleep refreshment from Visit 2 to Visits 4, 5, and 6. -(Cohort A)Change in PHQ-9 total score from Visit 2 to Visits 3, 4, 5, and 6. -(Cohort B)Change in GAD-7 total score from Visit 2 to Visits 3, 4, 5, and 6. | — |
Contacts
Public ContactTomoko Kubo
EPS Corporation
Outcome results
None listed