Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance

Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance - Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007737

Enrollment

Registered

2012-10-31

Start date

2012-04-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with primary insomnia and the circadian rhythm sleep disorder is diagnosed with the DSM diagnostic criteria and has it or more 6 points of Pittsburgh Sleep Quality Index

Interventions

The group of oral administration approximately one hour after the supper back at 8 mg of ramelteon once once a day The group of oral administration before bedtime at 8 mg of ramelteon once once a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with insomnia that primary insomnia and circadian rhythm sleep disorder are diagnosed with the DSM diagnostic criteria and have it or more 6 points of Pittsburgh Sleep Quality Index

Exclusion criteria

Exclusion criteria: The patients with a history of hypersensitivity for ramelteon The patients with serious hepatic disorder The patients receiving the fluvoxamine The women with during the pregnancy or the possibility to pregnancy

Design outcomes

Primary

Measure	Time frame
Pittsburgh Sleep Quality Index Sleep scan	—

Secondary

Measure	Time frame
clock gene RNA expression	—

Countries

Japan

Contacts

Public ContactKenichi Osada

St. Marianna University School Of Medicine Neuropsychiatry

k2osada@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026