Major Depressive Disorder Clinical Trial
Official title:
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
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.
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