The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder.

The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder. - The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005744

Enrollment

Registered

2011-06-13

Start date

2011-06-01

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

circadian rhythm sleep disorder

Interventions

ramelteon administration(4mg, once a day, 7h bofore average sleep-onset time) melatonin administration (1mg, once a day, 7h bofore average sleep-onst time)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient with circadian rhythm sleep disorder diagnosed by International Crassification of Sleep Disorders.

Exclusion criteria

Exclusion criteria: Patients with active co-morbidities including severe conditions. Heart failure, liver failure, renal failure, severe infection. Pregnancy, breast feeding and suspected pregnancy. Under treatment of Fluvoxamine Maleate.

Design outcomes

Primary

Measure	Time frame
sleep-onset time, wakeup time, slee ptime, dim light meratonin onsettime	—

Countries

Japan

Contacts

Public ContactYuichi Kamei

National Center Hospital, National Center of Neurology and Psychiatry Department of Laboratory Medicine

Outcome results

None listed

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