Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blue light
bright light
dim light
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring nonseasonal major depression disorder, light therapy
Eligibility Criteria
Inclusion Criteria:
- meet criteria for major depressive episodes as determined by MINI
- HAMD17≥17
- received antidepressive medication at stable dosages for at least 14 days
Exclusion Criteria:
- Any axis I psychiatric disorder comorbidity
- who have received formal psychological therapy, MECT or rTMS in 3 months
- any current significant medical condition especially eye diseases
- serious suicide risk
- pregnant or breastfeeding women
- depression with seasonal pattern
- treatment-resistant depression
- epilepsy in the past
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
blue light group
bright light group
dim light group
Arm Description
The blue light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.
The bright light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.
The dim light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.
Outcomes
Primary Outcome Measures
Change in 17-item Hamilton Depression Rating Scale (HAMD17)
It assesses the severity of depression symptom. The responder on HAMD17 is defined as a HAMD17 decrease at least 50% from the baseline at post-treatment.
Secondary Outcome Measures
Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)
It's a self-rated inventory which assesses the severity of depression symptom
Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
It assesses the severity of anxiety symptom.
Change in Pittsburgh sleep quality index (PSQI)
It assesses the quality of sleep.
Change in Clinical Global Impression scale(CGI)
It gives an overall clinical impression to the continuous outcome measures.
Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
It assesses the quality of life, enjoyment and satisfaction
Change in Morningness-Eveningness Questionnaire (MEQ)
It assesses the circadian phase
Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
It assesses cognitive function
Change in subjective fatigue symptom scale
It assesses subjective fatigue symptom related to the light therapy
Change in semantic differential scale
It assesses subjective feeling related to the light therapy
Full Information
NCT ID
NCT04555408
First Posted
September 15, 2020
Last Updated
September 15, 2020
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District, Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04555408
Brief Title
Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
Official Title
Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District, Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.
Detailed Description
The current study aims to compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults. 162 patients with nonseasonal MDD will be randomized into three groups (i.e. blue light, bright light or dim light). The treatment will be performed five times a week for the first two weeks. And for the next 2 weeks, the treatment for patients will be undertook three times a week. There will be 16 times in total. The investigators will assess nonseasonal MDD'symptom severity in the baseline, 1 week,2 week, 4 week,6 week and 8 week. Through the study, 17-item Hamilton Depression Rating Scale (HAMD17),14-item Hamilton Anxiety Rating Scale (HAMA14),Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR),Pittsburgh sleep quality index (PSQI) , Clinical Global Impression scale(CGI), Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q),Morningness-Eveningness Questionnaire (MEQ),Repeatable Battery for the Assessment of Neuropsychological Status(RBANS),subjective fatigue symptom scale and semantic differential scale will be obtained. The patients will also get individual's data of heart rate and blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
nonseasonal major depression disorder, light therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
blue light group
Arm Type
Active Comparator
Arm Description
The blue light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.
Arm Title
bright light group
Arm Type
Active Comparator
Arm Description
The bright light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.
Arm Title
dim light group
Arm Type
Placebo Comparator
Arm Description
The dim light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.
Intervention Type
Device
Intervention Name(s)
blue light
Intervention Description
Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.
Intervention Type
Device
Intervention Name(s)
bright light
Intervention Description
Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.
Intervention Type
Device
Intervention Name(s)
dim light
Intervention Description
Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.
Primary Outcome Measure Information:
Title
Change in 17-item Hamilton Depression Rating Scale (HAMD17)
Description
It assesses the severity of depression symptom. The responder on HAMD17 is defined as a HAMD17 decrease at least 50% from the baseline at post-treatment.
Time Frame
from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)
Description
It's a self-rated inventory which assesses the severity of depression symptom
Time Frame
from baseline to 8 weeks
Title
Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
Description
It assesses the severity of anxiety symptom.
Time Frame
from baseline to 8 weeks
Title
Change in Pittsburgh sleep quality index (PSQI)
Description
It assesses the quality of sleep.
Time Frame
from baseline to 8 weeks
Title
Change in Clinical Global Impression scale(CGI)
Description
It gives an overall clinical impression to the continuous outcome measures.
Time Frame
from baseline to 8 weeks
Title
Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
It assesses the quality of life, enjoyment and satisfaction
Time Frame
from baseline to 8 weeks
Title
Change in Morningness-Eveningness Questionnaire (MEQ)
Description
It assesses the circadian phase
Time Frame
from baseline to 8 weeks
Title
Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
Description
It assesses cognitive function
Time Frame
from baseline to 8 weeks
Title
Change in subjective fatigue symptom scale
Description
It assesses subjective fatigue symptom related to the light therapy
Time Frame
from baseline to 8 weeks
Title
Change in semantic differential scale
Description
It assesses subjective feeling related to the light therapy
Time Frame
from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
meet criteria for major depressive episodes as determined by MINI
HAMD17≥17
received antidepressive medication at stable dosages for at least 14 days
Exclusion Criteria:
Any axis I psychiatric disorder comorbidity
who have received formal psychological therapy, MECT or rTMS in 3 months
any current significant medical condition especially eye diseases
serious suicide risk
pregnant or breastfeeding women
depression with seasonal pattern
treatment-resistant depression
epilepsy in the past
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Wang, MD
Phone
64041990
Email
wang.yuan@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Huang, MD,PhD
Phone
64041990
Email
slehuang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Wang, MD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
We'll reach out to this number within 24 hrs