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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163143 | Registry Identifier | JapicCTI | |
| U1111-1177-4116 | Other Identifier | WHO |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon 8 mg | Experimental | Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | Ramelteon tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and the end of the Treatment Period (up to Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and the end of the Treatment Period (up to Week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| You Ariyoshi Sleep Clinic | Kitakyushu | Fukuoka | Japan | |||
| Ishikawa Mental Clinic |
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.
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Participants with a diagnosis of Major Depressive Disorder (MDD) with Insomnia were enrolled in 1 treatment arm: Ramelteon 8 mg.
Participants took part in the study at 7 investigative sites in Japan from 09 May 2017 to 31 January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon 8 mg | Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS) was defined as all participants given at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon 8 mg | Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS) was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | minutes | Baseline and the end of the Treatment Period (up to Week 8) |
|
Up to Week 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon 8 mg | Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infections | Infections and infestations | MedDRA version: 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2018 | Jan 30, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 31, 2017 | May 17, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and the end of the Treatment Period (up to Week 8) |
| Sapporo |
| Hokkaido |
| Japan |
| Minami 1jo Mental Clinic | Sapporo | Hokkaido | Japan |
| Senzoku Psychosomatic Clinic | Meguro City | Tokyo | Japan |
| Sangenjaya Neurology and Psychosomatic Clinic | Setagaya City | Tokyo | Japan |
| Himorogi Kokorono Clinic | Shinjuku | Tokyo | Japan |
| Seiwa Hospital | Shinjuku | Tokyo | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Body Mass Index (BMI)=weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Classification | Count of Participants | Participants |
|
| Alcohol Consumption Per Week | Count of Participants | Participants |
|
| Duration of Insomnia | Mean duration between the first diagnosis of insomnia and the start of the study was reported. | Mean | Standard Deviation | years |
|
| Duration of Depression | Mean duration between the first diagnosis of depression and the start of the study was reported. | Mean | Standard Deviation | years |
|
| Sleep Latency by Actigraphy | 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 | Standard Deviation | minutes |
|
| Sleep Latency by Sleep Diary | 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 | Standard Deviation | minutes |
|
| Total Nocturnal Sleep Time by Actigraphy | 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 | Standard Deviation | minutes |
|
| Total Nocturnal Sleep Time by Sleep Diary | Total nocturnal sleep time by diary was calculated as total time in bed (awaking hour - bedtime hour) from which sleep latency was subtracted. | Mean | Standard Deviation | minutes |
|
| Number of Nocturnal Awakenings by Actigraphy | The number of nocturnal awakenings were assessed by actigraphy which is a non-intrusive tool that measures an individual's movement during sleep. | Mean | Standard Deviation | nocturnal awakenings |
|
| Number of Nocturnal Awakenings by Sleep Diary | The number of nocturnal awakenings were recorded by the participant in a diary. | Mean | Standard Deviation | nocturnal awakenings |
|
| Nocturnal Wake Time by Actigraphy | 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 | Standard Deviation | minutes |
|
| Sleep Efficiency by Actigraphy | 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 | Standard Deviation | percentage of sleep |
|
| Daytime Activity Level by Actigraphy | Daytime activity level, as evaluated by the number of footsteps, was assessed by actigraphy, a non-intrusive tool that measures an individual's movement. | Mean | Standard Deviation | steps |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | minutes | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | minutes | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | minutes | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | nocturnal awakenings | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | percentage of sleep | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | minutes | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | nocturnal awakenings | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| Secondary | 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. | FAS was defined as all participants given at least 1 dose of study drug. | Posted | Mean | Standard Deviation | steps | Baseline and the end of the Treatment Period (up to Week 8) |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 9 |
| 26 |
| Somnolence | Nervous system disorders | MedDRA version: 20.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D001523 |
| Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |