Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9
研究概览
简要总结
Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate the neural networks of the human brain and improve cognitive performance in healthy subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the investigators will study the effect of transcranial bright light treatment via ear canals on depressive and anxiety symptoms in patients suffering from SAD in randomized controlled double-blind study design.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern
- •Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
- •patient is over 18 years and under 66 years
- •patient can read and understand the subject information sheet
- •patient has signed the informed consent form
- •patient is not pregnant
排除标准
- •patient has a lifetime psychotic disorder
- •patient has a bipolar disorder
- •patient has alcohol or some other substance use dependence or misuse
- •patient has some unstable somatic disorder
- •patient uses some psychotropic agencies
- •patient is, in the opinion of the investigator, unsuitable for any reason
- •patient is a member of the site personnel or their immediate families
- •patient has administered bright light therapy via ear canals during the current episode
结局指标
主要结局
Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9
时间窗: At the end of the four week study period
Remission, i.e., Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version total score ≤ 9
次要结局
- Beck Depression Inventory-II, total score <=10(At the end of the four week study period)
- State Trait Anxiety Inventory -Y2, total score(At the end of the four week study period)
- Trail- making test (TMT-A and TMT-B),total time(At the end of the four weeks study period)
研究者
Heidi Jurvelin
Research coordinator
University of Oulu