The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy

Inclusion Criteria

• •1. Has difficulty in initiating sleep at least 3 days per week for at least 4 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.