CompletedNot Applicable

Melatonin Receptor Agonist and Peripheral Biological Markers

40 participantsStarted 2016-01-11

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

The Change from Baseline Hamilton depression rating scale at 8 weeks

Timeframe: 8 weeks

Trial details

NCT IDNCT03432091

SponsorNational Science and Technology Council, Taiwan

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2018-12-31

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