Dosing-time-dependent effects of ramelteon on delirium prevention: a randomized controlled trial

Dosing-time-dependent effects of ramelteon on delirium prevention: a randomized controlled trial - Dosing-time-dependent effects of ramelteon on delirium prevention: a RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042259

Enrollment

150

Registered

2021-04-01

Start date

2021-04-01

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

delirium

Interventions

Intervention: Ramelteon 8mg at 19:00 every night for 6 days Control: Ramelteon 8mg at 21:00 every night for 6 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hospitalized patients because of acute disease or elective surgery, with delirium on the night before the consultation

Exclusion criteria

Exclusion criteria: Patients who still alter arousal at the time of consultation Patients who take CYP3A inhibitors, antipsychotics, antidepressants, hypnotics, and anxiolytics Patients with substance related disorders, narcolepsy, and cataplexy Patients with severe liver or respiratory dysfunction

Design outcomes

Primary

Measure	Time frame
Incidence of delirium, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, during the first 7 days	—

Secondary

Measure	Time frame
Change in the score of sleep-wake cycle as defined by the Delirium Rating Scale-Revised-98	—

Countries

Japan

Contacts

Public ContactKotaro Hatta

Juntendo University Nerima Hospital Department of Psychiatry

khatta@juntendo.ac.jp03-5923-3111

Outcome results

None listed

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