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

Fudan University

Status: Unknown

Conditions: Depression

Treatments: Device: blue light; Device: dim light; Device: bright light

Study type: Interventional

Funder types: Other

Identifiers

NCT04555408

2019ZSQN44

Details and patient eligibility

About

To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.

Full 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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 3 patient groups, including a placebo group

blue light group

Active Comparator group

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.

Treatment:

Device: blue light

bright light group

Active Comparator group

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.

Treatment:

Device: bright light

dim light group

Placebo Comparator group

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.

Treatment:

Device: dim light