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
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- 入组人数
- 26
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Refer to conclusion of "Adverse Events" and "Secondary Outcome Measures" sections.
研究者
入排标准
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.
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
结局指标
主要结局
未指定
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