The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Condition: Insomnia; Major Depressive Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Ramelteon
Intervention description: Ramelteon tablets
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Drug Therapy

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.
    

Eligibility criteria:

        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.

        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.