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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027998
Receipt No. R000031934
Scientific Title The effect of sunglass as a mood stabilizer: a randomized controlled trial
Date of disclosure of the study information 2017/07/01
Last modified on 2019/06/01

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Basic information
Public title The effect of sunglass as a mood
stabilizer: a randomized controlled trial
Acronym The effect of sunglass as a mood
stabilizer: a randomized controlled trial
Scientific Title The effect of sunglass as a mood
stabilizer: a randomized controlled trial
Scientific Title:Acronym The effect of sunglass as a mood
stabilizer: a randomized controlled trial
Region
Japan

Condition
Condition Bipolar Disorder, manic or hypomanic
episode
Major Depressive Disorder with mixed
features
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare mood stabilizing effects
between orange sunglasses,gray sunglasses,and transparent glasses.
Basic objectives2 Others
Basic objectives -Others To compare circadian rhythm between
depression and bipolar disorder and to
investigate changes in circadian rhythm
due to sunglasses
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Psychiatric symptoms are assessed by
Young Mania Rating Scale(YMRS)and
Hamilton Depression Rating Scale(HDRS)
one week before and just before wearing
sunglasses and one, two, three, four
weeks later.
Key secondary outcomes Circadian rhythm are measured by actigram
for five weeks from one week before
wearing sunglasses.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 4weeks
Interventions/Control_2 4weeks
Interventions/Control_3 4weeks
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Inpatients and outpatients aged 20 or
more, providing written informed consent
Key exclusion criteria 1.Patients unlikely to continue the study
due to serious psychiatric or physical
diseases.
2.Inappropriate patients judged by a
doctor for this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Terao
Organization Oita University Faculty of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1 Idaigaoka, Hasamamachi, Yufu, Oita,879-5593, Japan
TEL 097-549-4411
Email terao@oit-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanao Shirahama
Organization Oita University Faculty of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1 Idaigaoka, Hasamamachi, Yufu, Oita,879-5593, Japan
TEL 097-549-4411
Homepage URL
Email masa97@oit-u.ac.jp

Sponsor
Institute Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization via self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 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 7
Results
Greysunglasses seem to be effective.
Results date posted
2019 Year 05 Month 31 Day
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 06 Month 13 Day
Date of IRB
2017 Year 06 Month 14 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2022 Year 05 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
2017 Year 06 Month 29 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031934

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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