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

September 15, 2020 updated by: Shanghai Zhongshan Hospital
To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: blue light group
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.
Device: blue light
Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.
Active Comparator: bright light group
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.
Device: bright light
Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.
Placebo Comparator: dim light group
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.
Device: dim light
Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 17-item Hamilton Depression Rating Scale (HAMD17)
Time Frame: 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.
from baseline to 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Fudan University
Shanghai Mental Health Center, Jingan District
Shanghai Mental Health Center, Yangpu District

Investigators

  • Principal Investigator: Yuan Wang, MD, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019ZSQN44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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