InsomniaNCT03432091
Melatonin Receptor Agonist and Peripheral Biological Markers
An observational study of Insomnia, run by National Science and Technology Council, Taiwan.
Trial summary
People who have insomnia typically co-occur with mental disorders, especially anxiety and depression. It has been documented that the melatonin phase in the depressed patients was reached with a delay. Melatonin plays a crucial role in regulation of circadian-clock-related gene expression. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Insomnia
- What is being tested?
- melatonin
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2016to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Out-patients with primary insomnia and patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD) with chief complaint of insomnia or a history of daytime complaint(s) associated with disturbed sleep. The diagnosis of MDD and GAD will be made made according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) Revised for at least 3 months. 2. Patients are 20-80 years old, body mass index between 18 and 34, and without any ambulatory problems.
Who may be able to join
- Out-patients with primary insomnia and patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD) with chief complaint of insomnia or a history of daytime complaint(s) associated with disturbed sleep. The diagnosis of MDD and GAD will be made made according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) Revised for at least 3 months.
- Patients are 20-80 years old, body mass index between 18 and 34, and without any ambulatory problems.
- Subject is a male or a post-menopausal female. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- If they willing to give written informed consent and cooperative in this study. They are willing to write sleep diary.
- Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the lead-in period.
- Habitual bedtime is between 8:30 PM and 12:00 AM.
Who cannot join
- Known hypersensitivity to ramelteon or related compounds, including melatonin.
- Previously participated in a study involving ramelteon.
- Participated in any other investigational study, and/or took any investigational drug within 30 days or five half-lives prior to the first day of single-blind study medication, whichever is longer.
- Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
- Participated in a weight loss program or substantially altered exercise routine within 30 days prior to the first day of single blind study medication.
- Has ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
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- History of substance use disorders, such drug addiction, drug abuse, alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
- History of drug addiction or drug abuse within the past 12 months.
- Positive hepatitis panels.
About this study
Official title: Effects of a Melatonin Receptor Agonist on Clinical Manifestations and Peripheral Biological Markers of Circadian Rhythm
People who have insomnia typically co-occur with mental disorders, especially anxiety and depression. It has been documented that the melatonin phase in the depressed patients was reached with a delay. Melatonin plays a crucial role in regulation of circadian-clock-related gene expression.
Read the detailed description
The higher values of circadian-clock-related proteins observed at day (brain and muscle aryl hydrocarbon receptor nuclear translocator-like protein 1 and circadian locomoter output cycles protein kaput1) and night (period circadian protein homolog 1 and cryptochrome). Melatonin receptor type 1 (MT1) and melatonin receptor type 2 (MT2) are present in mammals including humans and involved in sleep-wake cycle. RamelteonRMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders; however, the effects of the melatonin receptor agonist on peripheral biological markers of circadian rhythm are still to elucidate. This is a non-randomized, observational study, which aims of this study is to evaluate the effects of ramelteon RMT in melatonin level and the regulation of circadian rhythm genes expression in patients with primary insomnia, and/or major depressive disorder (MDD) on, or generalized anxiety disorder (GAD) with symptoms of insomnia. Forty Participants: Participants aged 20-80 years with body mass index between 18 and 34 and without any ambulatory problems will be recruited according to clinical judgment to take RMT for insomnia, ages 20-80 years, body mass index between 18 and 34, without any ambulatory problems, and be willing to write sleep diary. Primary insomnia, MDD and GAD will be as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep. Participants were administered the ramelteon RMT tablet (8 mg/Tab) by oral intake at the same time, which is 2 hours prior to the schedule bedtime every night for eight weeks. The peripheral blood is collected at two time points - ramelteon RMT administration week 0 and week 8, and the melatonin, circadian-clock-related day genes (Aryl hydrocarbon receptor nuclear translocator-like protein 1 and Circadian locomoter output cycles protein kaput1) and night genes (circadian protein homolog 1 and cryptochrome) expression variation will be quantified and compared to determine circadian rhythm phase shift. The expected findings are the circadian-clock-related genes would shift to normal baseline and these genes expressions will be the peripheral marker for evaluation of drug treatment efficacy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
Ramelteon RMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change from Baseline Hamilton depression rating scale at 8 weeks
This scale scores 0-64 points;The higher total score indicates a more severe
Measured: 8 weeks
Secondary outcomes (1)
The Change from Baseline pittsburgh sleep quality index rating scale at 8 weeks
This scale scores 0-21 points;The higher total score indicates a more severe
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start11 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
- Investigators
- Kuan-Pin Su, MD PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432091
- Sponsor's protocol ID
- CMUH104-REC1-105
- Status last verified
- Oct 2022
- First submitted
- 7 Feb 2018
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Melatonin Receptor Agonist on Clinical Manifestations and Peripheral Biological Markers of Circadian Rhythm
- ClinicalTrials.gov ID
- NCT03432091
- Acronym / sponsor ID
- CMUH104-REC1-105
- Conditions
- Insomnia
- Keywords
- melatonin, melatonin receptor agonist, circadian-clock-related genes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who have insomnia typically co-occur with mental disorders, especially anxiety and depression. It has been documented that the melatonin phase in the depressed patients was reached with a delay. Melatonin plays a crucial role in regulation of circadian-clock-related gene expression.
Detailed description
The higher values of circadian-clock-related proteins observed at day (brain and muscle aryl hydrocarbon receptor nuclear translocator-like protein 1 and circadian locomoter output cycles protein kaput1) and night (period circadian protein homolog 1 and cryptochrome). Melatonin receptor type 1 (MT1) and melatonin receptor type 2 (MT2) are present in mammals including humans and involved in sleep-wake cycle. RamelteonRMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders; however, the effects of the melatonin receptor agonist on peripheral biological markers of circadian rhythm are still to elucidate. This is a non-randomized, observational study, which aims of this study is to evaluate the effects of ramelteon RMT in melatonin level and the regulation of circadian rhythm genes expression in patients with primary insomnia, and/or major depressive disorder (MDD) on, or generalized anxiety disorder (GAD) with symptoms of insomnia. Forty Participants: Participants aged 20-80 years with body mass index between 18 and 34 and without any ambulatory problems will be recruited according to clinical judgment to take RMT for insomnia, ages 20-80 years, body mass index between 18 and 34, without any ambulatory problems, and be willing to write sleep diary. Primary insomnia, MDD and GAD will be as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep. Participants were administered the ramelteon RMT tablet (8 mg/Tab) by oral intake at the same time, which is 2 hours prior to the schedule bedtime every night for eight weeks. The peripheral blood is collected at two time points - ramelteon RMT administration week 0 and week 8, and the melatonin, circadian-clock-related day genes (Aryl hydrocarbon receptor nuclear translocator-like protein 1 and Circadian locomoter output cycles protein kaput1) and night genes (circadian protein homolog 1 and cryptochrome) expression variation will be quantified and compared to determine circadian rhythm phase shift. The expected findings are the circadian-clock-related genes would shift to normal baseline and these genes expressions will be the peripheral marker for evaluation of drug treatment efficacy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Out-patients with primary insomnia and patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD) with chief complaint of insomnia or a history of daytime complaint(s) associated with disturbed sleep. The diagnosis of MDD and GAD will be made made according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) Revised for at least 3 months. 2. Patients are 20-80 years old, body mass index between 18 and 34, and without any ambulatory problems.
Key inclusion criteria (6 listed)
- Out-patients with primary insomnia and patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD) with chief complaint of insomnia or a history of daytime complaint(s) associated with disturbed sleep. The diagnosis of MDD and GAD will be made made according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) Revised for at least 3 months.
- Patients are 20-80 years old, body mass index between 18 and 34, and without any ambulatory problems.
- Subject is a male or a post-menopausal female. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- If they willing to give written informed consent and cooperative in this study. They are willing to write sleep diary.
- Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the lead-in period.
Key exclusion criteria (9 listed)
- Known hypersensitivity to ramelteon or related compounds, including melatonin.
- Previously participated in a study involving ramelteon.
- Participated in any other investigational study, and/or took any investigational drug within 30 days or five half-lives prior to the first day of single-blind study medication, whichever is longer.
- Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
- Participated in a weight loss program or substantially altered exercise routine within 30 days prior to the first day of single blind study medication.
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 |
|---|---|---|
| melatoninRamelteon RMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders | Drug | – |
Primary outcome
The Change from Baseline Hamilton depression rating scale at 8 weeks
Time frame: 8 weeks
This scale scores 0-64 points;The higher total score indicates a more severe
1 secondary outcome
The Change from Baseline pittsburgh sleep quality index rating scale at 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Kuan-Pin Su, MD PhD principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by National Science and Technology Council, Taiwan.
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 6 inclusion and 9 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Change from Baseline Hamilton depression rating scale at 8 weeks (time frame: 8 weeks). 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 10 Oct 2022.