UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the blue light-blocking glasses in major depressive disorder
Title of the study (Brief title)	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	Yuichi Esaki
Organization	Okehazama Hospital
Division name	Medical office
Address	3-879 sakae minamikan, toyoake, aichi
TEL	0562-97-1361
Email	esakiz@fujita-hu.ac.jp

Public contact
Name of contact person	Yuichi Esaki
Organization	Okehazama Hospital
Division name	Medical office
Address	3-879 sakae minamikan, toyoake, aichi
TEL	0562-97-1361
Homepage URL
Email	esakiz@fujita-hu.ac.jp

Sponsor
Institute	Okehazama Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024464