UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005591 |
|---|---|
| Receipt number | R000006612 |
| Scientific Title | Prediction and prevention of delirium |
| Date of disclosure of the study information | 2011/05/12 |
| Last modified on | 2015/04/03 12:49:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prediction and prevention of delirium
Acronym
Prediction and prevention of delirium
Scientific Title
Prediction and prevention of delirium
Scientific Title:Acronym
Prediction and prevention of delirium
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we aim to examine whether ramelteon is effective for prevention of delirium, or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of delirium
Key secondary outcomes
1. discontinuation due to adverse phenomenon
2. association between values of IL-1beta and NK activity and subsequent delirium
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Ramelteon
Interventions/Control_2
placebo
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients newly admitted to emergency department
Key exclusion criteria
1) Severe liver dysfunction
2) Patients given fluvoxamine
3) Alcohol dependence, amphetamine abuse
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
TEL
03-5923-3111
khatta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
TEL
03-5923-3111
Homepage URL
khatta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂大学練馬病院（東京都）、東京医科歯科大学病院（東京都）、日本医大武蔵小杉病院（神奈川県）、北里大学病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、広島市民病院（広島県）、東京都保健医療公社豊島病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results: Ramelteon was associated with lower risk of delirium (3% vs. 32%, P=.003), with a relative risk of 0.09 (95% confidence interval (CI), 0.01-0.69). Even after controlling for risk factors, ramelteon was still associated with a lower incidence of delirium (P=.01; odds ratio, 0.07; 95%CI, 0.008-0.54). Kaplan-Meier estimates of time to development of delirium were 6.94 days (95%CI, 6.82-7.06 days) for ramelteon and 5.74 days (5.05-6.42 days) for placebo. Comparison by log-rank test showed that the frequency of developing delirium was significantly lower in patients taking ramelteon than in those taking placebo (X2=9.83, P=.002).
Conclusions and Relevance: Ramelteon administered nightly to elderly patients admitted for acute care may provide protection against delirium. This finding supports a possible pathogenic role of melatonin neurotransmission in delirium.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 07 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 14 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 12 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006612
