UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042259
Receipt number R000048086
Scientific Title Dosing-time-dependent effects of ramelteon on delirium prevention: a randomized controlled trial
Date of disclosure of the study information 2021/04/01
Last modified on 2022/10/30 12:23:16

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name