UMIN-CTR Clinical Trial

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://center6.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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