Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 162
- 主要终点
- Change in 17-item Hamilton Depression Rating Scale (HAMD17)
研究概览
简要总结
To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.
详细描述
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.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet criteria for major depressive episodes as determined by MINI
- •HAMD17≥17
- •received antidepressive medication at stable dosages for at least 14 days
排除标准
- •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
结局指标
主要结局
Change in 17-item Hamilton Depression Rating Scale (HAMD17)
时间窗: from baseline to 8 weeks
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.
次要结局
- Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)(from baseline to 8 weeks)
- Change in Pittsburgh sleep quality index (PSQI)(from baseline to 8 weeks)
- Change in Clinical Global Impression scale(CGI)(from baseline to 8 weeks)
- Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(from baseline to 8 weeks)
- Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)(from baseline to 8 weeks)
- Change in Morningness-Eveningness Questionnaire (MEQ)(from baseline to 8 weeks)
- Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)(from baseline to 8 weeks)
- Change in subjective fatigue symptom scale(from baseline to 8 weeks)
- Change in semantic differential scale(from baseline to 8 weeks)