UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021216 |
|---|---|
| Receipt number | R000024464 |
| Scientific Title | Effect of the blue light-blocking glasses in major depressive disorder |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2016/08/17 09:09:10 |
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Basic information
Public title
Effect of the blue light-blocking glasses in major depressive disorder
Acronym
Effect of the blue light-blocking glasses in MDD
Scientific Title
Effect of the blue light-blocking glasses in major depressive disorder
Scientific Title:Acronym
Effect of the blue light-blocking glasses in MDD
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate of efficacy and safety for blue light blocking glasses in major depressive disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS (visual analogue mood scales)for assessment of sleep quality
baseline and after treatment (2 weeks)
Key secondary outcomes
HAM-D (Hamilton Rating Scale for Depression)
BDI (Beck Depression Inventory)
CGI (Clinical global impression)
MEQ (morning and evening question)
sleep daily
baseline and after treatment (2 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear blue light blocking glasses from 20:00 until bedtime every evening for two weeks.
Interventions/Control_2
Wear placebo glasses (blocking only ultraviolet light) from 20:00 until bedtime every evening for two weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) diagnosis of major depressive disorders outpatient.
20-65 years of age, male and female.
Agree to the participation in study.
A score of more than 13 on the 17 item Hamilton Depressive Scale (HAM-D 17).
Complain of sleep onset insomnia.
Key exclusion criteria
Patient who has difficulty in wearing of the glasses.
Marked suicidal ideation.
Patient who judged that a doctor was inappropriate.
seasonal affective disorder, bipolar and psychotic disorders, substance abuse, shift work
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Esaki |
Organization
Okehazama Hospital
Division name
Medical office
Zip code
Address
3-879 sakae minamikan, toyoake, aichi
TEL
0562-97-1361
esakiz@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Esaki |
Organization
Okehazama Hospital
Division name
Medical office
Zip code
Address
3-879 sakae minamikan, toyoake, aichi
TEL
0562-97-1361
Homepage URL
esakiz@fujita-hu.ac.jp
Sponsor or person
Institute
Okehazama Hospital
Institute
Department
Personal name
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
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
| 2016 | Year | 02 | Month | 29 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 07 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 26 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024464
