UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019300
Receipt No. R000022241
Scientific Title Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis
Date of disclosure of the study information 2015/10/09
Last modified on 2019/04/15

* 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 Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis
Acronym Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis
Scientific Title Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis
Scientific Title:Acronym Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The objectives is to elucidate the effect of psychotropics on driving performance, cognitive function, neural basis of central nervous system, and stress responsiveness.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Driving performance by driving simulator
Key secondary outcomes Cognitive performance (attention, executive function, memory), equibalent function, Stanford sleepiness scale, fMRI, gene polymorphism, and stress related substance

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Blood alcohol concentration 0.025% single dose
Interventions/Control_2 Blood alcohol concentration 0.05% single dose
Interventions/Control_3 Blood alcohol concentration 0.09% single dose
Interventions/Control_4 Placebo
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
65 years-old >
Gender Male
Key inclusion criteria Healthy adult men who have a driving license and from whom written informed consent was obtained
Key exclusion criteria Female, patients with physical and psychiatric disorders, under 20 years old and over 55 years old
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Norio
Middle name
Last name Ozaki
Organization Nagoya University Graduate School of Medicine
Division name Psychiatry
Zip code 466-8550
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Email ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kunihiro
Middle name
Last name Iwamoto
Organization Nagoya University Graduate School of Medicine
Division name Psychiatry
Zip code 466-8550
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Homepage URL
Email iwamoto@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Nagoya University Graduate School of Medicine and Nagoya University Hospital ethics review committee
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
Tel 052-744-2479
Email ethics@med.nagoya-u.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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 09 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 Enrolling by invitation
Date of protocol fixation
2005 Year 05 Month 30 Day
Date of IRB
2010 Year 06 Month 28 Day
Anticipated trial start date
2018 Year 06 Month 27 Day
Last follow-up date
2020 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We recruit healthy perticipants without history of psychiatric disorders who do not take psychotrophics

Management information
Registered date
2015 Year 10 Month 09 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.