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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blue light
bright light
dim light
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring nonseasonal major depression disorder, light therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    blue light group

    bright light group

    dim light group

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
    It assesses the severity of anxiety symptom.
    Change in Pittsburgh sleep quality index (PSQI)
    It assesses the quality of sleep.
    Change in Clinical Global Impression scale(CGI)
    It gives an overall clinical impression to the continuous outcome measures.
    Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
    It assesses the quality of life, enjoyment and satisfaction
    Change in Morningness-Eveningness Questionnaire (MEQ)
    It assesses the circadian phase
    Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
    It assesses cognitive function
    Change in subjective fatigue symptom scale
    It assesses subjective fatigue symptom related to the light therapy
    Change in semantic differential scale
    It assesses subjective feeling related to the light therapy

    Full Information

    First Posted
    September 15, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Shanghai Zhongshan Hospital
    Collaborators
    Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District, Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04555408
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital
    Collaborators
    Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District, Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    nonseasonal major depression disorder, light therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    162 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    blue light group
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    bright light group
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    dim light group
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    blue light
    Intervention Description
    Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.
    Intervention Type
    Device
    Intervention Name(s)
    bright light
    Intervention Description
    Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.
    Intervention Type
    Device
    Intervention Name(s)
    dim light
    Intervention Description
    Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.
    Primary Outcome Measure Information:
    Title
    Change in 17-item Hamilton Depression Rating Scale (HAMD17)
    Description
    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.
    Time Frame
    from baseline to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)
    Description
    It's a self-rated inventory which assesses the severity of depression symptom
    Time Frame
    from baseline to 8 weeks
    Title
    Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
    Description
    It assesses the severity of anxiety symptom.
    Time Frame
    from baseline to 8 weeks
    Title
    Change in Pittsburgh sleep quality index (PSQI)
    Description
    It assesses the quality of sleep.
    Time Frame
    from baseline to 8 weeks
    Title
    Change in Clinical Global Impression scale(CGI)
    Description
    It gives an overall clinical impression to the continuous outcome measures.
    Time Frame
    from baseline to 8 weeks
    Title
    Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
    Description
    It assesses the quality of life, enjoyment and satisfaction
    Time Frame
    from baseline to 8 weeks
    Title
    Change in Morningness-Eveningness Questionnaire (MEQ)
    Description
    It assesses the circadian phase
    Time Frame
    from baseline to 8 weeks
    Title
    Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
    Description
    It assesses cognitive function
    Time Frame
    from baseline to 8 weeks
    Title
    Change in subjective fatigue symptom scale
    Description
    It assesses subjective fatigue symptom related to the light therapy
    Time Frame
    from baseline to 8 weeks
    Title
    Change in semantic differential scale
    Description
    It assesses subjective feeling related to the light therapy
    Time Frame
    from baseline to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan Wang, MD
    Phone
    64041990
    Email
    wang.yuan@zs-hospital.sh.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiao Huang, MD,PhD
    Phone
    64041990
    Email
    slehuang@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuan Wang, MD
    Organizational Affiliation
    Shanghai Zhongshan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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