NCT02669082

The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Insomnia
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon tablets

Timeline

• Start date: 2017-05-09
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2016-01-29
• Last updated: 2019-07-22
• Results posted: 2019-07-22

Locations

7 sites across 1 country: Japan