UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027998 |
|---|---|
| Receipt number | 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 10:22:08 |
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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
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
masa97@oit-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031934
