Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive Disorder in Chinese Population
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Light terapy
pseudo-light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
1)Meets DSM-5 criteria for major depressive disorder 2) Age 18-65; 3) HAMD-17 score ≥17; 4) No antidepressants or mood stabilizers were used at least 2 weeks before enrollment; 5) Sign informed consent.
Exclusion Criteria:
- With seasonal pattern;
- No previous mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma, cerebrovascular diseases caused by organic diseases;
- No previous history of alcohol or substance dependence;
- Current serious risk of suicide (e.g., previous attempted suicide or recent suicidal behavior); 5)Present with serious, active physical diseases that may interfere with research, including vision problems and photosensitivity disorders; 6)Have received electroconvulsive therapy (ECT or MECT) or transcranial magnetic stimulation (rTMS) in the last 6 months.
Sites / Locations
- Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antidepressant and light treatment group
Antidepressants and pseudo-light therapy
Arm Description
Outcomes
Primary Outcome Measures
remission of acute phase
scored 7 or lower on the Hamilton's Depression Scale with 17 items
Secondary Outcome Measures
Full Information
NCT ID
NCT05499117
First Posted
August 11, 2022
Last Updated
August 11, 2022
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT05499117
Brief Title
Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive Disorder in Chinese Population
Official Title
Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
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
Depression is a kind of mental illness with high incidence, high recurrence and high disability. But so far, treatment remission rates for depression remain low. Therefore, it is necessary to develop more new treatments. Light therapy has been shown to be effective in treating depression with seasonal patterns. Although most studies have reported that light therapy is also effective in patients with depression without seasonal patterns, high-quality clinical studies are still rare and the conclusions are still controversial. In particular, it remains unclear whether light therapy is effective in treating depression without seasonal patterns in the Chinese population. In addition, there is a lack of biomarkers that predict the efficacy of light therapy.
In conclusion, this study intends to conduct an ADD-ON randomized controlled study to clarify the efficacy and safety of light therapy as synergistic therapy in patients with depression without seasonal patterns, and to screen peripheral biomarkers related to efficacy using transcriptome sequencing technology. It is expected that this study can confirm the effectiveness and safety of light therapy as synergistic therapy, provide an evidence-based basis for the research and exploration of light therapy in Chinese depression population, and provide more options for the synergistic treatment of antidepressants in Chinese depression population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antidepressant and light treatment group
Arm Type
Active Comparator
Arm Title
Antidepressants and pseudo-light therapy
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Light terapy
Other Intervention Name(s)
fluoxetine
Intervention Description
Carex Day-Light Classic, Light intensity is white Light, 10000UX, and color temperature is 4000K
Intervention Type
Device
Intervention Name(s)
pseudo-light therapy
Other Intervention Name(s)
fluoxetine
Intervention Description
The pseudo-light stimulation group was red light with intensity less than 100lux
Primary Outcome Measure Information:
Title
remission of acute phase
Description
scored 7 or lower on the Hamilton's Depression Scale with 17 items
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1)Meets DSM-5 criteria for major depressive disorder 2) Age 18-65; 3) HAMD-17 score ≥17; 4) No antidepressants or mood stabilizers were used at least 2 weeks before enrollment; 5) Sign informed consent.
Exclusion Criteria:
With seasonal pattern;
No previous mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma, cerebrovascular diseases caused by organic diseases;
No previous history of alcohol or substance dependence;
Current serious risk of suicide (e.g., previous attempted suicide or recent suicidal behavior); 5)Present with serious, active physical diseases that may interfere with research, including vision problems and photosensitivity disorders; 6)Have received electroconvulsive therapy (ECT or MECT) or transcranial magnetic stimulation (rTMS) in the last 6 months.
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daihui Peng, M.D.,Ph.D.
Phone
18017311136
Email
pdhsh@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive Disorder in Chinese Population
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