Melatonin Receptor Agonist and Peripheral Biological Markers

NCT03432091 | Completed

• 1 other identifier: CMUH104-REC1-105
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Insomnia

Keywords

melatonin; melatonin receptor agonist; circadian-clock-related genes

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (1)

• The Change from Baseline pittsburgh sleep quality index rating scale at 8 weeks

  8 weeks

Interventions

melatonin DRUG

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kuan-Pin Su, MD PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of psychiatry

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 13, 2018
• Study Start: January 11, 2016
• Primary Completion: December 31, 2018
• Study Completion: July 31, 2019
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share