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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | The effect of sunglass as a mood
stabilizer: a randomized controlled trial |
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Acronym | The effect of sunglass as a mood
stabilizer: a randomized controlled trial |
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Scientific Title | The effect of sunglass as a mood
stabilizer: a randomized controlled trial |
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Scientific Title:Acronym | The effect of sunglass as a mood
stabilizer: a randomized controlled trial |
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Region |
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Condition | ||
Condition | Bipolar Disorder, manic or hypomanic
episode Major Depressive Disorder with mixed features |
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Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Inpatients and outpatients aged 20 or
more, providing written informed consent |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |