Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder

Conditions
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Depression

Intervention / Treatment
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* Device: blue light
* Device: bright light
* Device: dim light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: blue light group<br>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. | Device: blue light<br>* Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.<br>|
| Active Comparator: bright light group<br>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. | Device: bright light<br>* Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.<br>|
| Placebo Comparator: dim light group<br>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. | Device: dim light<br>* Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from baseline to 8 weeks | 
| Change in 14-item Hamilton Anxiety Rating Scale (HAMA14) | It assesses the severity of anxiety symptom. | from baseline to 8 weeks | 
| Change in Pittsburgh sleep quality index (PSQI) | It assesses the quality of sleep. | from baseline to 8 weeks | 
| Change in Clinical Global Impression scale(CGI) | It gives an overall clinical impression to the continuous outcome measures. | from baseline to 8 weeks | 
| Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | It assesses the quality of life, enjoyment and satisfaction | from baseline to 8 weeks | 
| Change in Morningness-Eveningness Questionnaire (MEQ) | It assesses the circadian phase | from baseline to 8 weeks | 
| Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS) | It assesses cognitive function | from baseline to 8 weeks | 
| Change in subjective fatigue symptom scale | It assesses subjective fatigue symptom related to the light therapy | from baseline to 8 weeks | 
| Change in semantic differential scale | It assesses subjective feeling related to the light therapy | from baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonseasonal major depression disorder, light therapy