UMIN-CTR Clinical Trial

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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