The placebo controlled randomized double blind multicenter study to investigate effectiveness and safety of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia.

UMIN ID: UMIN000026332

Registered date:28/02/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic insomnia
• Date of first enrollment: 2018/01/04
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Co-administer following medication for 12 weeks since informed consent; R group: taking capsule of Ramelteon 8mg once daily before sleeping.
Co-administer following medication for 12 weeks since informed consent; PL group: taking capsule of Placebo once daily before sleeping.

Outcome(s)

• Primary Outcome: The achievement ratio of the 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12weeks or withdrawal without any deterioration of insomnia symptoms The rate of subjects who achieved more than 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12 weeks or withdrawal since informed consent.
• Secondary Outcome: 1) The achievement ratio of the 50% dose reduction (Diazepam conversion value) at 4weeks and 8weeks 2) The average of the dose reduction rate at 4weeks, 8weeks and 12weeks 3) The achievement ratio of the 100% dose reduction at 12weeks or withdrawal 4) The variation in total score of PSQI and AIS at 4weeks, 8weeks and 12weeks 5) The variation in PHQ-9 score at 4weeks, 8weeks and 12weeks 6) CIWA-B score at 4weeks, 8weeks and 12weeks 7) PGI score at 12weeks or withdrawal

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Subjects meeting any of the following criteria will not be included in the study: 1. Patients with secondary insomnia 2. Patients taking (non-)BZD hypnotics at a dose exceeding 2-fold of the usual dose 3. Patients taking barbiturate and non-barbiturate hypnotics and Suvorexant. 4. Patients taking hypnotics other than medicinal pharmaceuticals (including OTC, supplements believed to be effective for insomnia and melatonin) 5. Patients taking mianserin hydrochloride, mirtazapine, and trazodone hydrochloride 6. Patients taking antipsychotics 7. Patients taking anxiolytic or clonazepam at bedtime *Patient taking anxiolytic and/or clonazepam at times except for bed-time will be included in the study. However, dosage and timing of administration can not be changed during the study period. 8. Patients who took ramelteon within 1 month prior to the informed consent 9. Patients in whom the dose of psychotropics except for the items 2-7 were changed within 1 month prior to the informed consent 10. Patients who are comorbid with depression or bipolar disordeand and in whom depressive symptoms have not remitted 11. Patients in whom frequency in Q9 of PHQ "thoughts that you would be better off dead or thoughts of hurting yourself in some way" is "more than half the days (in the past 2 weeks)" or the total score is 10 or higher 12. Patients with dementia, schizophrenia, drug dependence and alcoholic 13. Patients with liver/kidney disorder, female subjects who are pregnant or in breast-feeding, and malignant neoplasm 14. Night workers 15. Patients meeting contraindications for ramelteon 16. Other patients judged ineligible for participation in the study by the investigator

Related Information

• Primary Sponsor: Yoyogi Sleep Disorder Clinic Foundation of Sleep and Health Science
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited