UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028239 |
|---|---|
| Receipt number | R000032194 |
| Scientific Title | Association between light exposure at daily life and pathology of bipolar disorder: Cross-sectional study |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2024/01/19 11:59:23 |
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Basic information
Public title
Association between light exposure at daily life and pathology of bipolar disorder: Cross-sectional study
Acronym
Association between light exposure at daily life and pathology of BD
Scientific Title
Association between light exposure at daily life and pathology of bipolar disorder: Cross-sectional study
Scientific Title:Acronym
Association between light exposure at daily life and pathology of BD
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we evaluate the associations of daytime and nighttime light exposure in daily life with symptoms of bipolar disorder.
Basic objectives2
Others
Basic objectives -Others
we evaluate the associations of daytime and nighttime light exposure in daily life with symptoms of bipolar disorder.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the associations of daytime and nighttime light exposure in daily life with symptoms of bipolar disorder
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) diagnosis of bipolar disorders outpatient.
Key exclusion criteria
Marked suicidal ideation
shift work
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Esaki |
| Middle name | |
| Last name | Yuichi |
Organization
Okehazama Hospital
Division name
Medical office
Zip code
470-1168
Address
3-879 sakae minamikan, toyoake, aichi
TEL
0562-97-1361
esakiz@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Esaki |
| Middle name | |
| Last name | Yuichi |
Organization
Okehazama Hospital
Division name
Medical office
Zip code
470-1168
Address
3-879 sakae minamikan, toyoake, aichi
TEL
0562-97-1361
Homepage URL
esakiz@fujita-hu.ac.jp
Sponsor or person
Institute
Okehazama Hospital
Institute
Department
Personal name
Funding Source
Organization
Non profit organization
The Neuroscience Research Center
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
Okehazama hospital
Address
3-879 sakae minamikan, toyoake, aichi
Tel
0562-97-1361
esakiz@fujita-hu.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
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Test results have not yet been published
Publication of results
Unpublished
Result
URL related to results and publications
Test results have not yet been published
Number of participants that the trial has enrolled
218
Results
Test results have not yet been published
Results date posted
| 2024 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Test results have not yet been published
Participant flow
Test results have not yet been published
Adverse events
Test results have not yet been published
Outcome measures
Test results have not yet been published
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 08 | Month | 02 | Day |
Date analysis concluded
Other
Other related information
1 Study design - Cross-Sectional design
2 Recruitment method - Patients recruit from Okehazama Hospital, Fujita Mental Care Satellite Zengo, and Fujita Mental Care Satellite Tokushige.
3 Assessment
daytime and nighttime light exposure
Montgomery asberg Depression Rating Scale
Young Mania Rating Scale
sleep diary
Insomnia Severity Index
morning and evening question
Actiwatch
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032194
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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