UMIN-CTR Clinical Trial

Basic information
Public title	Dosing-time-dependent effects of ramelteon on delirium prevention: a randomized controlled trial
Acronym	Dosing-time-dependent effects of ramelteon on delirium prevention: a RCT
Scientific Title	Dosing-time-dependent effects of ramelteon on delirium prevention: a randomized controlled trial
Scientific Title:Acronym	Dosing-time-dependent effects of ramelteon on delirium prevention: a RCT
Region	Japan

Condition
Condition	delirium
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In a prospective observational study, we have reported that the incidence of delirium in patients taking ramelteon at 19:00 was much lower than that in patients taking ramelteon at 21:00 among patients with delirium on the night before the consultation. We examine this finding in a randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of delirium, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, during the first 7 days
Key secondary outcomes	Change in the score of sleep-wake cycle as defined by the Delirium Rating Scale-Revised-98

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Intervention: Ramelteon 8mg at 19:00 every night for 6 days
Interventions/Control_2	Control: Ramelteon 8mg at 21:00 every night for 6 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hospitalized patients because of acute disease or elective surgery, with delirium on the night before the consultation
Key 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
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Kotaro Middle name Last name Hatta
Organization	Juntendo University Nerima Hospital
Division name	Department of Psychiatry
Zip code	177-8521
Address	3-1-10 Takanodai, Nerima-ku, Tokyo
TEL	03-5923-3111
Email	khatta@juntendo.ac.jp

Public contact
Name of contact person	1st name Kotaro Middle name Last name Hatta
Organization	Juntendo University Nerima Hospital
Division name	Department of Psychiatry
Zip code	177-8521
Address	3-1-10 Takanodai, Nerima-ku, Tokyo
TEL	03-5923-3111
Homepage URL
Email	khatta@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS KAKENHI Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Juntendo University Nerima Hospital
Address	3-1-10 Takanodai, Nerima-ku, Tokyo
Tel	03-5923-3111
Email	gcp@juntendo-nerima.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学医学部附属練馬病院（東京都）、日本医科大学武蔵小杉病院（神奈川県）、東京医科歯科大学病院（東京都）、東京医科大学茨城医療センター（茨城県）、順天堂大学医学部附属江東高齢者医療センター（東京都）、順天堂大学医学部附属浦安病院（千葉県）、福山市民病院（広島県）、広島市立広島市民病院（広島県）

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
Results	The number of planned incorporations was far short of the planned number, and the hypothesis could not be verified.
Results date posted	2022 Year 10 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	none
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 09 Month 14 Day
Date of IRB	2020 Year 10 Month 06 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 10 Month 06 Day
Date of closure to data entry	2022 Year 10 Month 06 Day
Date trial data considered complete	2022 Year 10 Month 06 Day
Date analysis concluded	2022 Year 10 Month 06 Day

Other
Other related information

Management information
Registered date	2020 Year 10 Month 27 Day
Last modified on	2022 Year 10 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048086