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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007537
Receipt No. 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 2017/09/26

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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
Middle name
Last name Terao, Takeshi
Organization Oita university, faculty of medicine
Division name department of neuropsychiatry
Zip code
Address 1-1 idaigaoka, hasama-machi, yufu-city, oita prefacture
TEL 097-586-5823
Email terao@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohno, Kentaro
Organization Oita university, faculty of medicine
Division name department of neuropsychiatry
Zip code
Address 1-1 idaigaoka, hasama-machi, yufu-city, oita prefacture
TEL 097-586-5823
Homepage URL
Email kentarokohno@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

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
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
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
2017 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008906

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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