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

NCT05499117 | Unknown

• 1 other identifier: 2021-HY-006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• remission of acute phase

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

  8 weeks

Study Arms (2)

Antidepressant and light treatment group

ACTIVE COMPARATOR

Device: Light terapy

Antidepressants and pseudo-light therapy

PLACEBO COMPARATOR

Device: pseudo-light therapy

Interventions

Light terapy DEVICE

Carex Day-Light Classic, Light intensity is white Light, 10000UX, and color temperature is 4000K

Also known as: fluoxetine

Antidepressant and light treatment group

pseudo-light therapy DEVICE

The pseudo-light stimulation group was red light with intensity less than 100lux

Also known as: fluoxetine

Antidepressants and pseudo-light therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: February 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-02

Locations

CN (1)