UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015681 |
|---|---|
| Receipt number | R000018227 |
| Scientific Title | Delirium prevention and prediction,Part 2 |
| Date of disclosure of the study information | 2015/02/28 |
| Last modified on | 2020/12/03 18:20:43 |
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Basic information
Public title
Delirium prevention and prediction,Part 2
Acronym
Delirium prevention and prediction,Part 2
Scientific Title
Delirium prevention and prediction,Part 2
Scientific Title:Acronym
Delirium prevention and prediction,Part 2
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether suvolexant is effective for the prevention of delirium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of delirium as determined by the DSM-5.
Key secondary outcomes
1. Estimates of the probability of developing delirium
2. Change in inflammatory markers
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
suvolexant
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 due to emergency, and able to take medicine orally
Key exclusion criteria
Patients who have an expected stay or life expectancy less than 2 night
Target sample size
78
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
Takanodai 3-1-10, Nerima-ku, Tokyo 177-8521, Japan
TEL
+81-3-5923-3111
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
Takanodai 3-1-10, Nerima-ku, Tokyo 177-8521, Japan
TEL
+81-3-5923-3111
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 (Grant-in-Aid for Scientific Research C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nippon Medical School Musashikosugi Hospital
Hiroshima City Hospital
Tokyo Medical and Dental University
Kanazawa University Graduate School of Medical Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Juntendo University Nerima Hospital
Address
Takanodai 3-1-10, Nerima-ku, Tokyo 177-8521, Japan
Tel
+81359233111
khatta@juntendo.ac.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）
東京医科歯科大学病院（東京都）
日本医科大学附属武蔵小杉病院（神奈川県）
広島市立広島市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
http://doi.org/10.4088/JCP.16m11194
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.4088/JCP.16m11194
Number of participants that the trial has enrolled
72
Results
We found that development of delirium occurred significantly less often among patients taking suvorexant than those taking placebo (0% [n/N=0/36] vs.17% [6/36], P=.025). Comparison by log-rank test also showed that development of delirium occurred significantly less often among patients taking suvorexant than those taking placebo (chi-square=6.46, P=.011). Analysis of variance revealed a tendency for main effect of treatment (F=3.79, P=.053) on Sleep-wake cycle disturbance score (item 1) of DRS-R98-J.
Results date posted
| 2020 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were 65-89 years old, newly admitted due to emergency, and able to take medicine orally, and had an expected stay or life expectancy 48 h or more.
Participant flow
Seventy-two patients were randomly assigned using the sealed envelope method to receive suvorexant (15 mg/day; 36 patients) and placebo (36 patients) every night for three days.
Adverse events
There were no significant differences in adverse events.
Outcome measures
The primary outcome measure was incidence of delirium as determined by the DSM-5.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018227
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
