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

Not Applicable

• Conditions: Depression
• Interventions: Device: dim light; Device: blue light; Device: bright light

• Registration Number: NCT04555408
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-18
• Last Update Posted: 2020-09-18
• Study Start: 2020-10-01
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dim light group	dim light	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.
blue light group	blue light	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.
bright light group	bright light	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.

Primary Outcome Measures

Name	Time	Method
Change in 17-item Hamilton Depression Rating Scale (HAMD17)	from baseline to 8 weeks	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

Name	Time	Method
Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)	from baseline to 8 weeks	It assesses the severity of anxiety symptom.
Change in Pittsburgh sleep quality index (PSQI)	from baseline to 8 weeks	It assesses the quality of sleep.
Change in Clinical Global Impression scale(CGI)	from baseline to 8 weeks	It gives an overall clinical impression to the continuous outcome measures.
Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	from baseline to 8 weeks	It assesses the quality of life, enjoyment and satisfaction
Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)	from baseline to 8 weeks	It's a self-rated inventory which assesses the severity of depression symptom
Change in Morningness-Eveningness Questionnaire (MEQ)	from baseline to 8 weeks	It assesses the circadian phase
Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)	from baseline to 8 weeks	It assesses cognitive function
Change in subjective fatigue symptom scale	from baseline to 8 weeks	It assesses subjective fatigue symptom related to the light therapy
Change in semantic differential scale	from baseline to 8 weeks	It assesses subjective feeling related to the light therapy