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

* 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

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 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


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

Value
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