Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive Disorder in Chinese Population

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05499117
Collaborator
(none)
80
1
2
17.9
4.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Light terapy
  • Device: pseudo-light therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Antidepressant and light treatment group

Device: Light terapy
Carex Day-Light Classic, Light intensity is white Light, 10000UX, and color temperature is 4000K
Other Names:
  • fluoxetine
  • Placebo Comparator: Antidepressants and pseudo-light therapy

    Device: pseudo-light therapy
    The pseudo-light stimulation group was red light with intensity less than 100lux
    Other Names:
  • fluoxetine
  • Outcome Measures

    Primary Outcome Measures

    1. remission of acute phase [8 weeks]

      scored 7 or lower on the Hamilton's Depression Scale with 17 items

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    1. With seasonal pattern;

    2. No previous mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma, cerebrovascular diseases caused by organic diseases;

    3. No previous history of alcohol or substance dependence;

    4. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Mental Health Center Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT05499117
    Other Study ID Numbers:
    • 2021-HY-006
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022