An observational study in Insomnia, sponsored by National Science Council, Taiwan. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by National Science Council, Taiwan · Observational
People who have insomnia typically co-occur with mental disorders, especially anxiety and depression. It has been documented that the melatonin phase in the depressed patients was reached with a delay. Melatonin plays a crucial role in regulation of circadian-clock-related gene expression.
The higher values of circadian-clock-related proteins observed at day (brain and muscle aryl hydrocarbon receptor nuclear translocator-like protein 1 and circadian locomoter output cycles protein kaput1) and night (period circadian protein homolog 1 and cryptochrome). Melatonin receptor type 1 (MT1) and melatonin receptor type 2 (MT2) are present in mammals including humans and involved in sleep-wake cycle. RamelteonRMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders; however, the effects of the melatonin receptor agonist on peripheral biological markers of circadian rhythm are still to elucidate. This is a non-randomized, observational study, which aims of this study is to evaluate the effects of ramelteon RMT in melatonin level and the regulation of circadian rhythm genes expression in patients with primary insomnia, and/or major depressive disorder (MDD) on, or generalized anxiety disorder (GAD) with symptoms of insomnia. Forty Participants: Participants aged 20-80 years with body mass index between 18 and 34 and without any ambulatory problems will be recruited according to clinical judgment to take RMT for insomnia, ages 20-80 years, body mass index between 18 and 34, without any ambulatory problems, and be willing to write sleep diary. Primary insomnia, MDD and GAD will be as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep. Participants were administered the ramelteon RMT tablet (8 mg/Tab) by oral intake at the same time, which is 2 hours prior to the schedule bedtime every night for eight weeks. The peripheral blood is collected at two time points - ramelteon RMT administration week 0 and week 8, and the melatonin, circadian-clock-related day genes (Aryl hydrocarbon receptor nuclear translocator-like protein 1 and Circadian locomoter output cycles protein kaput1) and night genes (circadian protein homolog 1 and cryptochrome) expression variation will be quantified and compared to determine circadian rhythm phase shift. The expected findings are the circadian-clock-related genes would shift to normal baseline and these genes expressions will be the peripheral marker for evaluation of drug treatment efficacy.
Exclusion Criteria:
Ramelteon RMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders
The Change from Baseline Hamilton depression rating scale at 8 weeks
This scale scores 0-64 points;The higher total score indicates a more severe
Time frame: 8 weeks
The Change from Baseline pittsburgh sleep quality index rating scale at 8 weeks
This scale scores 0-21 points;The higher total score indicates a more severe
Time frame: 8 weeks
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Plan to share: No
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National Science Council, Taiwan