UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023576 |
|---|---|
| Receipt number | R000027154 |
| Scientific Title | Effect of caffeine on neuropsychological performance and driving ability in healthy volunteers: a double-blind placebo-controlled study. |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2016/08/10 07:41:23 |
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Basic information
Public title
Effect of caffeine on neuropsychological performance and driving ability in healthy volunteers: a double-blind placebo-controlled study.
Acronym
Effect of caffeine on neuropsychological performance and driving ability in healthy volunteers: a double-blind placebo-controlled study.
Scientific Title
Effect of caffeine on neuropsychological performance and driving ability in healthy volunteers: a double-blind placebo-controlled study.
Scientific Title:Acronym
Effect of caffeine on neuropsychological performance and driving ability in healthy volunteers: a double-blind placebo-controlled study.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of the present study is to investigate the effect of caffeine intake on cognitive functions in healthy volunterrs.
Basic objectives2
Others
Basic objectives -Others
The aim of the present study is to investigate the effect of caffeine intake on driving performance in healthy volunterrs.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Driving performance using driving simulator
Key secondary outcomes
Cognitive function test
Circadian rhythm,Sleep efficiency,amount of activity
Quantitative EEG
Udvalg for Kliniske Undersogelser
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Effects of caffeine intake on cognitive functions in healthy volunterrs.
Interventions/Control_2
Effects of caffeine intake on driving performance in healthy volunterrs.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A)The subjects defined mentally healthy ones using the SCID-I-RV/NP
B)Inclusion criteria were having a valid driving license.
C)The patients who can be signed informed consent were enrolled in the present study.
Key exclusion criteria
The subjects met any mental disorders criteria using the Structured Clinical interview for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), and had taken caffeine 3 days within the experiments.
The subjects who have any history of psychiatric diseases.
The subjects who had histories of gastric ulcer.
The subjects who had histories of cardiovascular disorders.
The subjects who have histories of glaucoma.
Women in pregnant or willing to pregnant.
Women under breast-feeding.
The subjects who physicians consider not to be suited.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUKI KONISHI |
Organization
University of Occupational and Environmental Health
Division name
depertment of psychiatry
Zip code
Address
kitakyuusyuu 8078555, JAPAN
TEL
0936917523
konikoni0125@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUKI KONISHI |
Organization
University of Occupational and Environmental Health
Division name
depertment of psychiatry
Zip code
Address
kitakyuusyuu 8078555, JAPAN
TEL
0936917523
Homepage URL
konikoni0125@hotmail.co.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 10 | 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
Results
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027154
