UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056064 |
|---|---|
| Receipt number | R000064065 |
| Scientific Title | The Effect of Bright Light Therapy on Patients with Mood Disorders: A Combined Analysis Using Neuroimaging and Genetic Polymorphisms. |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/05 20:36:40 |
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Basic information
Public title
The Effect of Bright Light Therapy on Patients with Mood Disorders: A Combined Analysis Using Neuroimaging and Genetic Polymorphisms.
Acronym
The Effect of Bright Light Therapy on Patients with Mood Disorders: A Combined Analysis Using Neuroimaging and Genetic Polymorphisms.
Scientific Title
The Effect of Bright Light Therapy on Patients with Mood Disorders: A Combined Analysis Using Neuroimaging and Genetic Polymorphisms.
Scientific Title:Acronym
The Effect of Bright Light Therapy on Patients with Mood Disorders: A Combined Analysis Using Neuroimaging and Genetic Polymorphisms.
Region
| Japan |
Condition
Condition
Major depressive disorder, Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The primary objective is to examine whether bright light therapy in patients with mood disorders leads to differences in the degree of improvement in depressive symptoms, changes in the dentate gyrus volume of the hippocampus, and genetic variations related to hippocampal neurogenesis, mood disorders, and photosensitivity.
Basic objectives2
Others
Basic objectives -Others
The secondary objective is to examine how genetic differences related to hippocampal neurogenesis, mood disorders, and photosensitivity affect neuroimaging results, including the dentate gyrus of the hippocampus, in patients with mood disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Variations in genes related to hippocampal neurogenesis, mood disorders, and photosensitivity and changing of the dentate gyrus of the hippocampus
Key secondary outcomes
Neuroimaging and variations in genes related to hippocampal neurogenesis, mood disorders, and photosensitivity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients with mood disorders who participated in previous research ("Bright light therapy and brain imaging: A randomized controlled study: UMIN000019220") and provided written informed consent to participate in the present study.
Key exclusion criteria
Subjects who are judged as inappropriate one at the discretion of the doctors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Hirakawa |
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
hira-hiro@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Hirakawa |
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
Oita University
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study involving patients with mood disorders who participated in a previous study, " Bright light therapy and brain imaging: A randomized controlled study: UMIN000019220".
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064065
