UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019220 |
|---|---|
| Receipt number | 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 | 2024/04/08 09:19:20 |
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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
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
hira-hiro@oita-u.ac.jp
Sponsor or person
Institute
Takeshi Terao
Institute
Department
Personal name
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
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
| 2025 | 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
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022214
| 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 |
