UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007537 |
|---|---|
| Receipt number | R000008906 |
| Scientific Title | Functional brain imaging of temperament evoked by high-intensity light irradiation: A randomized controlled trial |
| Date of disclosure of the study information | 2012/03/20 |
| Last modified on | 2020/04/10 14:23:51 |
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Basic information
Public title
Functional brain imaging of temperament evoked by high-intensity light irradiation: A randomized controlled trial
Acronym
Functional brain imaging study of temperament using FDG-PET
Scientific Title
Functional brain imaging of temperament evoked by high-intensity light irradiation: A randomized controlled trial
Scientific Title:Acronym
Functional brain imaging study of temperament using FDG-PET
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using FDG-PET, to acquire functional brain imaging of bipolar temperament.
And to investigate the relationship between their temperament and lifestyle, light, mental state and so on.
Basic objectives2
Others
Basic objectives -Others
Differences in brain function due to conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain fuctional image
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High-intensity light irradiation
Interventions/Control_2
none
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy individuals over the age of 20 agreement is obtained in writing with respect to participation in this study.
Key exclusion criteria
a) People who are suffering from serious physical illness or, in severe mental illness.
b) During pregnancy, lactating women.
c) Subjects at the discretion of the doctors, it is judged inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Terao |
Organization
Oita university, faculty of medicine
Division name
department of neuropsychiatry
Zip code
8795593
Address
1-1 idaigaoka, hasama-machi, yufu-city, oita prefecture
TEL
097-586-5823
terao@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kohno |
Organization
Oita university, faculty of medicine
Division name
department of neuropsychiatry
Zip code
8795593
Address
1-1 idaigaoka, hasama-machi, yufu-city, oita prefecture
TEL
097-586-5823
Homepage URL
kentarokohno@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Scientific research funds
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
Oita University Hospital IRB
Address
1-1 idaigaoka, hasama-machi, yufu-city, oita prefecture
Tel
097-586-6110
gcrcjimu@oita-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
| 2012 | Year | 03 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 05 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 20 | Day |
Last modified on
| 2020 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008906
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
