InsomniaPhase 4NCT02669082
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
A Phase 4 study testing Ramelteon in people with Insomnia and Major Depressive Disorder, run by Takeda at 7 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Insomnia, Major Depressive Disorder
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesJapan
- Study dates
- 9 May 2017to 31 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
You Ariyoshi Sleep Clinic
Kitakyushu, Fukuoka
Senzoku Psychosomatic Clinic
Meguro City, Tokyo
Ishikawa Mental Clinic
Sapporo, Hokkaido
Minami 1jo Mental Clinic
Sapporo, Hokkaido
Sangenjaya Neurology and Psychosomatic Clinic
Setagaya City, Tokyo
Himorogi Kokorono Clinic
Shinjuku, Tokyo
Seiwa Hospital
Shinjuku, Tokyo
About this study
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.
Read the 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
- Being tested
- Ramelteon
- Keywords
- Drug Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem, TAK-375
Ramelteon tablets
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg | Experimental | Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks. Receives: Drug: Ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and the end of the Treatment Period (up to Week 8)
Secondary outcomes (8)
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.
Measured: Baseline and the end of the Treatment Period (up to Week 8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and the end of the Treatment Period (up to Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start9 May 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669082
- Sponsor's protocol ID
- Ramelteon-4002
- Other IDs
- JapicCTI-163143, U1111-1177-4116
- Status last verified
- May 2019
- First submitted
- 27 Jan 2016
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
- ClinicalTrials.gov ID
- NCT02669082
- Acronym / sponsor ID
- Ramelteon-4002
- Conditions
- Insomnia, Major Depressive Disorder
- Keywords
- Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg | Experimental | Drug: RamelteonRamelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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".
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamelteonAlso: Rozerem, TAK-375Ramelteon tablets | Drug | Ramelteon 8 mg |
Primary outcome
Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
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.
8 secondary outcomes
Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and the end of the Treatment Period (up to Week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Insomnia and Major Depressive Disorder, run by Takeda at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period (time frame: Baseline and the end of the Treatment Period (up to Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.