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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019220
Receipt No. R000022214
Scientific Title Bright light therapy and brain imaging: A randomized controlled study
Date of disclosure of the study information 2015/10/05
Last modified on 2019/04/05

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Basic information
Public title Bright light therapy and brain imaging: A randomized controlled study
Acronym Bright light therapy and brain imaging
Scientific Title Bright light therapy and brain imaging: A randomized controlled study
Scientific Title:Acronym Bright light therapy and brain imaging
Region
Japan

Condition
Condition Healthy adults
Mood disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to investigate neurogenesis induced by bright light thepary in comparison to dim light therapy using brain imaging such as MRI and FDG-PET.
Basic objectives2 Others
Basic objectives -Others Also, relevant factors associated with neurogenesis are identified such as mental state, temperament, circadian rhythm, cognition and executive function, BDNF, melatonin, lifestyle and so on.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Morphometric and functional brain imaging
Comparison of before and after intervention
Key secondary outcomes mental state, temperament, circadian rhythm, cognition and executive function, BDNF, melatonin, lifestyle and so on

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 High-intensity light irradiation to healthy adults: bright white light 10000 lux, 30 minutes in the morning, 28days, daily
Interventions/Control_2 Light irradiation to healthy adults: dim red light 50 lux, 30 minutes in the morning, 28days, daily
Interventions/Control_3 High-intensity light irradiation to affective disorder patients: bright white light 10000 lux, 30 minutes in the morning, 28days, daily
Interventions/Control_4 Light irradiation: dim red light 50 lux to affective disorder patients, 30 minutes in the morning, 28days, daily
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 adults or affective disorder patient 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.
b)During pregnancy, lactating women.
c)Subjects at discretion of the doctors who is judged inappropriate.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Terao Takeshi
Middle name
Last name Terao Takeshi
Organization Oita university, faculty of medicine
Division name Department of neuropsychiatry
Zip code 879-5593
Address 1-1 idaigaoka, hasama-machi, yufu-city, oita prefecture
TEL 097-586-5823
Email terao@oita-u.ac.jp

Public contact
Name of contact person
1st name Hirakawa Hirofumi
Middle name
Last name Hirakawa Hirofumi
Organization Oita university, faculty of medicine
Division name Department of neuropsychiatry
Zip code 879-5593
Address 1-1 idaigaoka, hasama-machi, yufu-city, oita prefecture
TEL 097-586-5823
Homepage URL
Email hira-hiro@oita-u.ac.jp

Sponsor
Institute Takeshi Terao
Institute
Department

Funding Source
Organization Scientific reseach funds
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Institutional Review Board of Oita University Faculty of Medicine
Address 1-1 idaigaoka, hasama-machi, yufu-city, oita prefecture
Tel 097-586-6110
Email 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 大分大学医学部附属病院(大分県)     Oita university hospital(oita prefecture)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 05 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
2015 Year 09 Month 12 Day
Date of IRB
2015 Year 08 Month 28 Day
Anticipated trial start date
2015 Year 10 Month 16 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 02 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022214

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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