UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019300 |
|---|---|
| Receipt number | 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 | 2022/10/14 09:25:56 |
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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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Zopiclone 7.5 mg single dose
Interventions/Control_2
Placebo
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
| 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
Pathophysiology of Mental Disorders
Zip code
466-8550
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL
+81527442282
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
iwamoto@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1747CP-4
Org. issuing International ID_1
Hakata Clinic Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人相生会（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
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
No longer recruiting
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
| 2025 | 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
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022241
