Last updated on August 2017

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Major Depressive Disorder | Insomnia
  • Age: Between 20 - 64 Years
  • Gender: Male or Female
  • Other:
    Has difficulty in initiating sleep at least 3 days per week for the last 4 weeks or
    longer 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).
    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.
    In the opinion of the principal investigator or investigator, is capable of
    understanding the contents of the study and complying with study requirements.
    Is capable of signing and dating the informed consent form in person before any study
    procedures.

You may not be eligible for this study if the following are true:

  • Has a history of hypersensitivity to ramelteon and melatonin.
    Has severe liver disorder.
    Took ramelteon within 4 weeks before the informed consent.
    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.
    Is participating in any other investigational or post-marketing clinical trial/study.
    For other reason, judged not appropriate for participation in this study by the
    principal investigator or investigator

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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