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
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
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
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
