Back to resultsThe Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Primary Purpose
Insomnia, Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Ramelteon
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
- Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
- Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
- Outpatient.
- Meets either of the following criteria based on the 17-item Hamilton Rating Scale for Depression (HAM-D17) both at the start of the run-in period and the start of the study treatment period: has a score of 2 for "6: Insomnia Early", or has a score of 1 for "6: Insomnia Early" AND a score of at least 3 in total for "7: Insomnia Middle" and "8: Insomnia Late".
- Has a total HAM-D17 score of 16 or under both at the start of the run-in period and the start of the study treatment period.
- Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
- Goes to bed routinely in a daily life (time for bed between 21.00 p.m. and 1.00 a.m. at least 4 days per week).
- Actigraphy shows at least 3 days with sleep latency 30 minutes or longer AND total nocturnal sleep time 6.5 hours or shorter on the same day during the run-in period.
- In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements.
- Is capable of signing and dating the informed consent form in person before any study procedures.
Exclusion Criteria:
- Has a history of hypersensitivity to ramelteon and melatonin.
- Has severe liver disorder.
- Took ramelteon within 4 weeks before the informed consent.
- Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
- Shift worker or night worker.
- Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
- Has a HAM-D17 score of at least 1 for"11: Suicide" at the start of the run-in period or the start of the study treatment period, or any suicide attempts within 24 weeks before or during the run-in period.
- Pregnant woman, nursing mother, or woman who plans to become pregnant or donate eggs before the informed consent, during the study period or within 4 weeks after the end of the study.
- Is participating in any other investigational or post-marketing clinical trial/study.
- For other reason, judged not appropriate for participation in this study by the principal investigator or investigator.
Sites / Locations
- You Ariyoshi Sleep Clinic
- Ishikawa Mental Clinic
- Minami 1jo Mental Clinic
- Senzoku Psychosomatic Clinic
- Sangenjaya Neurology and Psychosomatic Clinic
- Himorogi Kokorono Clinic
- Seiwa Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ramelteon 8 mg
Arm Description
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02669082
Brief Title
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Official Title
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Major Depressive Disorder
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramelteon 8 mg
Arm Type
Experimental
Arm Description
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem, TAK-375
Intervention Description
Ramelteon tablets
Primary Outcome Measure Information:
Title
Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period
Description
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)
Secondary Outcome Measure Information:
Title
Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period
Description
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)
Title
Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
Description
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)
Title
Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period
Description
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.
Time Frame
Baseline and the end of the Treatment Period (up to Week 8)
Title
Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
Description
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)
Title
Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period
Description
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)
Title
Change From Baseline in Diary-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
Description
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)
Title
Change From Baseline in Diary-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
Description
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)
Title
Change From Baseline in Actigraphy-Measured Daytime Activity Level, as Evaluated by the Number of Footsteps, at the End of the Treatment Period
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
Outpatient.
Meets either of the following criteria based on the 17-item Hamilton Rating Scale for Depression (HAM-D17) both at the start of the run-in period and the start of the study treatment period: has a score of 2 for "6: Insomnia Early", or has a score of 1 for "6: Insomnia Early" AND a score of at least 3 in total for "7: Insomnia Middle" and "8: Insomnia Late".
Has a total HAM-D17 score of 16 or under both at the start of the run-in period and the start of the study treatment period.
Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
Goes to bed routinely in a daily life (time for bed between 21.00 p.m. and 1.00 a.m. at least 4 days per week).
Actigraphy shows at least 3 days with sleep latency 30 minutes or longer AND total nocturnal sleep time 6.5 hours or shorter on the same day during the run-in period.
In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements.
Is capable of signing and dating the informed consent form in person before any study procedures.
Exclusion Criteria:
Has a history of hypersensitivity to ramelteon and melatonin.
Has severe liver disorder.
Took ramelteon within 4 weeks before the informed consent.
Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
Shift worker or night worker.
Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
Has a HAM-D17 score of at least 1 for"11: Suicide" at the start of the run-in period or the start of the study treatment period, or any suicide attempts within 24 weeks before or during the run-in period.
Pregnant woman, nursing mother, or woman who plans to become pregnant or donate eggs before the informed consent, during the study period or within 4 weeks after the end of the study.
Is participating in any other investigational or post-marketing clinical trial/study.
For other reason, judged not appropriate for participation in this study by the principal investigator or investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
You Ariyoshi Sleep Clinic
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Ishikawa Mental Clinic
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Minami 1jo Mental Clinic
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Senzoku Psychosomatic Clinic
City
Meguro
State/Province
Tokyo
Country
Japan
Facility Name
Sangenjaya Neurology and Psychosomatic Clinic
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Himorogi Kokorono Clinic
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Seiwa Hospital
City
Shinjuku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Learn more about this trial
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
We'll reach out to this number within 24 hrs