The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
The drug being tested in this study is called ramelteon. Ramelteon is being tested to treat people who have insomnia with depression. This study will look at sleep activity of participants who take ramelteon. The study will enroll approximately 30 patients. Participants will be administered: • Ramelteon 8 mg Participants will be asked to take 1 tablet orally at bedtime. This multi-center study will be conducted in Japan. The overall period to participate in this study is 9 weeks (Run-in period for 1 week and treatment period for 8 weeks). Participants will make multiple visits to clinic including the final visit 8 weeks after the start of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Ramelteon tablets
You Ariyoshi Sleep Clinic
Kitakyushu, Fukuoka, Japan
Ishikawa Mental Clinic
Sapporo, Hokkaido, Japan
Minami 1jo Mental Clinic
Sapporo, Hokkaido, Japan
Senzoku Psychosomatic Clinic
Meguro City, Tokyo, Japan
Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period
Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days was evaluated. A negative change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period
Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
Total nocturnal sleep time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Total nocturnal sleep time by actigraphy was total time in bed from which sleep latency, nocturnal wake time, and the time from waking up to leaving the bed were subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period
Nocturnal wake time is the total time that is scored between nocturnal sleep onset and final wake-up. Nocturnal wake time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates a worsening.
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Sangenjaya Neurology and Psychosomatic Clinic
Setagaya City, Tokyo, Japan
Himorogi Kokorono Clinic
Shinjuku, Tokyo, Japan
Seiwa Hospital
Shinjuku, Tokyo, Japan
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
The number of nocturnal awakenings were assessed by actigraphy which is a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each time point was evaluated. A positive change from Baseline indicates a worsening.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period
Sleep efficiency was defined as percentage of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed calculated as \[(Total sleep time/total time in bed) \* 100\]. Sleep efficiency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Diary-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
Total nocturnal sleep time by diary was calculated as total time in bed (awaking hour - bedtime hour) from which sleep latency was subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Diary-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
The number of nocturnal awakenings were recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Actigraphy-Measured Daytime Activity Level, as Evaluated by the Number of Footsteps, at the End of the Treatment Period
Daytime activity level, as evaluated by the number of footsteps, were assessed by actigraphy, a non-intrusive tool that measures an individual's movement. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Time frame: Baseline and the end of the Treatment Period (up to Week 8)