Clinical trial NCT04555408: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: nonseasonal major depression disorder
light therapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center, Jingan District
name: Shanghai Mental Health Center, Yangpu District
name: Fudan University
First posted: 2020-09-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in 17-item Hamilton Depression Rating Scale (HAMD17)
timeFrame: from baseline to 8 weeks
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)
timeFrame: from baseline to 8 weeks
measure: Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
timeFrame: from baseline to 8 weeks
measure: Change in Pittsburgh sleep quality index (PSQI)
timeFrame: from baseline to 8 weeks
measure: Change in Clinical Global Impression scale(CGI)
timeFrame: from baseline to 8 weeks
measure: Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: from baseline to 8 weeks
measure: Change in Morningness-Eveningness Questionnaire (MEQ)
timeFrame: from baseline to 8 weeks
measure: Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
timeFrame: from baseline to 8 weeks
measure: Change in subjective fatigue symptom scale
timeFrame: from baseline to 8 weeks
measure: Change in semantic differential scale
timeFrame: from baseline to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Yuan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: