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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023576
Receipt No. 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

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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
Email 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
Email konikoni0125@hotmail.co.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027154

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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