A study of the effectiveness of small dose and early phase administration of ramelteon for delayed slepp phase disorder(DSPD)

A study of the effectiveness of small dose and early phase administration of ramelteon for delayed slepp phase disorder(DSPD) - Small dose and early phase administration of ramelteon for DSPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024228

Enrollment

Registered

2016-10-01

Start date

2016-10-01

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

Delayed Sleep-Wake Sleep Disorder (Delayed Sleep Phase Disorder)

Interventions

1)Ramelteon 1mg(5 consecutive weeks taking) 2)Measure of salivary melatonin concentration. (before treatment (pre-medication) and after treatment (post-dose 5 weeks)) 1)placebo(5 consecutive weeks t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Outpatients with a diagnosis of delayed sleep-wake phase disorder(DSWPD)according to the International Classification of Sleep Disorders, 3rd edition(ICSD-3) 2)>= 15years old and having graduated from a junior highschool 3)Being able to provide informed consent

Exclusion criteria

Exclusion criteria: 1)Using melatonin or ramelteon 2)Using psycotropic agents 3)judged inapropriate by a physician for some other reason

Design outcomes

Primary

Measure	Time frame
DLMO (Dim Light Melatonin Onset) after 4 weeks of ramelteon treatment	—

Secondary

Measure	Time frame
Sleep onset time, offset time, and total sleep time recorded by sleep diary and actigraph	—

Countries

Japan

Contacts

Public ContactTSUYOSHI KITAJIMA

department of medicine department of psychiatry

tsuyoshi@fujita-hu.ac.jp0562-93-9001

Outcome results

None listed

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