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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04555408
Enrollment
162
Registered
2020-09-18
Start date
2020-10-01
Completion date
2022-12-31
Last updated
2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

nonseasonal major depression disorder, light therapy

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.

Interventions

Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.

Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.

DEVICEdim light

Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.

Sponsors

Shanghai Mental Health Center, Jingan District
CollaboratorOTHER
Shanghai Mental Health Center, Yangpu District
CollaboratorUNKNOWN
Fudan University
CollaboratorOTHER
Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in 17-item Hamilton Depression Rating Scale (HAMD17)from baseline to 8 weeksIt 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

MeasureTime frameDescription
Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)from baseline to 8 weeksIt assesses the severity of anxiety symptom.
Change in Pittsburgh sleep quality index (PSQI)from baseline to 8 weeksIt assesses the quality of sleep.
Change in Clinical Global Impression scale(CGI)from baseline to 8 weeksIt 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 weeksIt assesses the quality of life, enjoyment and satisfaction
Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)from baseline to 8 weeksIt's a self-rated inventory which assesses the severity of depression symptom
Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)from baseline to 8 weeksIt assesses cognitive function
Change in subjective fatigue symptom scalefrom baseline to 8 weeksIt assesses subjective fatigue symptom related to the light therapy
Change in semantic differential scalefrom baseline to 8 weeksIt assesses subjective feeling related to the light therapy
Change in Morningness-Eveningness Questionnaire (MEQ)from baseline to 8 weeksIt assesses the circadian phase

Contacts

Primary ContactYuan Wang, MD
wang.yuan@zs-hospital.sh.cn64041990
Backup ContactXiao Huang, MD,PhD
slehuang@163.com64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026