Adjunctive Bright Light Therapy for Patients With Depression at Different Time Period: A Randomized Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
The study would enroll depressed adolescents and adults with bipolar I or II disorder or major depressive disorder who are receiving stable psychiatric medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Participants would be randomly assigned to treatment with either 1,0000-lux bright white light therapy in the morning or 1,0000-lux bright white light therapy in the afternoon, or <100-lux dim red placebo light therapy in the afternoon (N=59 for each group). Participants would be treated for 6 weeks. Symptoms would be assessed every two weeks with the 24-items Hamilton Depression Scale, the Young Mania Rating Scale, and the Pittsburgh Sleep Quality Index; salivary melatonin and cortisol concentrations will be also measured.
详细描述
The investigators would divide the participants enrolled into three groups: adjunctive morning bright light therapy (BLT) group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 7:00~9:00 a.m.), adjunctive afternoon BLT group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 12:00~14:00 p.m.), adjunctive placebo therapy group (light intensity: <100lux, color: dark red, duration of each intervention session: 30min, time period of intervention: 12:00~14:00 p.m.).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-75 years old
- •Diagnosed using DSM-5 criteria based on the Structured Clinical Interview for Patient Edition (SCID-P) for adults or Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (Kiddie-SADS-PL) for adolescents for the diagnosis of bipolar I or II disorder or major depressive disorder
- •24-items Hamilton Depression Rating Scale score ≥ 20, Young Mania Rating Scale score < 6
- •Participants with bipolar disorder taking at least one mood stabilizer, and the types of drugs have not changed in one week;
- •Antidepressants can be taken, and the types of antidepressants have not changed in one week
- •Low-dose benzodiazepines can be used, with a maximum of 2 mg of lorazepam equivalent per day
- •Right-handed
- •Primary school education or above
- •Sign informed consents after a full explanation of this study.
排除标准
- •A history of brain organic disease or severe traumatic brain injury and severe physical disease;
- •Drug, alcohol or other psychoactive substance abusers
- •Severe suicide risk;
- •Received modified electric convulsion therapy (MECT) in the past three months
- •Comorbid with ophthalmic diseases (cataract, macular degeneration, glaucoma, retinitis pigmentosa, etc.) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
- •Taking photosensitive drugs (phenothiazines, antimalarials, propranolol, melatonin, hypericum, stimulants or NSAIDs)
结局指标
主要结局
response rate
时间窗: up to week 6
Participants with a decrease in 24-items Hamilton Depression Scale (HDRS) score of 50% or more from baseline. HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points.
次要结局
- manic/hypomanic conversion rate(week 2; week 4; week 6)
- side effect(week 2; week 4;week 6)
- sleep quality(week 2; week 4;week 6)
研究者
Kangguang Lin
Director
Guangzhou Psychiatric Hospital