Insomnia
Conditions
Interventions
investigational material(s)
Generic name etc : Ramelteon 8 mg
INN of investigational material : Ramelteon
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Admin
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has difficulty in initiating sleep at least 3 days per week for the least 4 consecutive weeks at the time of informed consent. 2. Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression. 3. Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent. 4. Outpatient. 5. Meets either of the following criteria based on the 17-item Hamilton Rating Scale for Depression (HAM-D17) both at the start of the run-in period and the start of the study treatment period: has a score of 2 for "6: Insomnia Early", or has a score of 1 for "6: Insomnia Early" AND a score of at least 3 in total for "7: Insomnia Middle" and "8: Insomnia Late". 6. Has a total HAM-D17 score of 16 or under both at the start of the run-in period and the start of the study treatment period. 7. Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period. 8. Goes to bed routinely in a daily life (time for bed between 21.00 p.m. and 1.00 a.m. at least 4 days per week). 9. Actigraphy shows at least 3 days with sleep latency 30 minutes or longer AND total nocturnal sleep time 6.5 hours or shorter on the same day during the run-in period. 10. In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements. 11. Is capable of signing and dating the informed consent form in person before any study procedures.
Exclusion criteria
Exclusion criteria: 1. Has a history of hypersensitivity to ramelteon and melatonin. 2. Has severe liver disorder. 3. Took ramelteon within 4 weeks before the informed consent. 4. Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period. 5. Shift worker or night worker. 6. Has complications of psychiatric or neurological diseases that affect sleep state other than depression. 7. Has a HAM-D17 score of at least 1 for"11: Suicide" at the start of the run-in period or the start of the study treatment period, or any suicide attempts within 24 weeks before or during the run-in period. 8. Pregnant woman, nursing mother, or woman who plans to become pregnant or donate eggs before the informed consent, during the study period or within 4 weeks after the end of the study. 9. Is participating in any other investigational or post-marketing clinical trial/study. 10. For other reason, judged not appropriate for participation in this study by the principal investigator or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period Time Frame: Baseline and the end of the Treatment Period (up to Week 8) Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days was evaluated. A negative change from Baseline indicates improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change from Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period Time Frame: Baseline and the end of the Treatment Period (up to Week 8) Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement. efficacy Change from Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period Time Frame: Baseline and the end of the Treatment Period (up to Week 8) Total nocturnal sleep time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Total nocturnal sleep time by actigraphy was total time in bed from which sleep latency, nocturnal wake time, and the time from waking up to leaving the bed were subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement. efficacy Change from Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period Time Frame: Baseline and the end of the Treatment Period (up to Week 8) Nocturnal wake time is the total time that is scored between nocturnal sleep onset and final wake-up. Nocturnal wake time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates a worsening. efficacy Change from Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period Time Frame: Baseline and the end of the Treatment Period (up to Week 8) The number of nocturnal awakenings were assessed by actigraphy which is a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each time point was evaluated. A pos | — |
Countries
Japan
Outcome results
None listed