跳至主要内容
临床试验/NCT05499117
NCT05499117Unknown不适用

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

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
remission of acute phase

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

remission of acute phase

时间窗: 8 weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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