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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028239
Receipt No. 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 2019/07/17

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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
Email 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
Email esakiz@fujita-hu.ac.jp

Sponsor
Institute Okehazama Hospital
Institute
Department

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
Email 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
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
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
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
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032194

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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