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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04555408
• Other study ID #: 2019ZSQN44
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: July 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Yuan Wang, MD
• Phone: 64041990
• Email: wang.yuan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• blue light
Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.
• bright light
Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.
• dim light
Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Fudan University, Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)	It assesses the severity of anxiety symptom.	from baseline to 8 weeks
Secondary	Change in Pittsburgh sleep quality index (PSQI)	It assesses the quality of sleep.	from baseline to 8 weeks
Secondary	Change in Clinical Global Impression scale(CGI)	It gives an overall clinical impression to the continuous outcome measures.	from baseline to 8 weeks
Secondary	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
Secondary	Change in Morningness-Eveningness Questionnaire (MEQ)	It assesses the circadian phase	from baseline to 8 weeks
Secondary	Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)	It assesses cognitive function	from baseline to 8 weeks
Secondary	Change in subjective fatigue symptom scale	It assesses subjective fatigue symptom related to the light therapy	from baseline to 8 weeks
Secondary	Change in semantic differential scale	It assesses subjective feeling related to the light therapy	from baseline to 8 weeks