JPRN-jRCT1080223089已完成4 期
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients with Major Depressive Disorder by using Actigraphy
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 26 人开始时间: 2016年1月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
Refer to conclusion of "Adverse Events" and "Secondary Outcome Measures" sections.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 for11: 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
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