The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Dep… (NCT02669082) | Clinical Trial Compass
CompletedPhase 4
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Japan26 participantsStarted 2017-05-09
Plain-language summary
The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
Who can participate
Age range20 Years – 64 Years
SexALL
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Inclusion criteria
✓. Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
✓. Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
✓. Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
✓. Outpatient.
✓. 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".
✓. 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.
✓. Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
✓. 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).
Exclusion criteria
✕. Has a history of hypersensitivity to ramelteon and melatonin.
✕. Has severe liver disorder.
✕. Took ramelteon within 4 weeks before the informed consent.
What they're measuring
1
Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)
. Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
✕. Shift worker or night worker.
✕. Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
✕. 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.
✕. 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.