An exploratory observational study to investigate patient background factors of Ramelteon responders

Not Applicable

• Conditions: Insomnia

• Registration Number: JPRN-UMIN000013271
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: o longer recruiting
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

1.A patient with a diagnosis of insomnia with difficulty falling asleep who has been started on treatment with oral Ramelteon 8 mg/day
2.A patient who has answered the Insomnia Severity Index (ISI) questionnaire and the health-related QOL scale Short Form-8 (SF-8) in routine clinical settings before the start of Ramelteon therapy
3.A patient who has given consent to the use of clinical information for the study at 20 years of age or older

Exclusion Criteria

1.A patient who has received Ramelteon within 4 weeks before the start of oral ramelteon therapy
2.A patient with dementia
3.A patient with a history of hypersensitivity to Ramelteon
4.A patient with severe hepatic impairment
5.A patient with a history of drug abuse
6.A patient with psychiatric disease in an unstable condition
7.A patient who, in the opinion of the principal investigator or co-investigator, is not appropriate for the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and patient background factors

Secondary Outcome Measures

Name	Time	Method
?Relationship between the change in the Physical Component Summary (PCS-8) score or Mental Component Summary (MCS-8) score, which are QOL variables measured by the health-related QOL scale Short Form-8 (SF-8), and patient background factors <br>?Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and the change in the QOL variable measured by the health-related QOL scale Short Form-8 (SF-8)