Gerandomiseerde en Gecontroleerde Studie Naar de Effecten Van Lichttoediening Met Een Hogere Kleurtemperatuur in Vergelijking Met de Standaard Lichttherapie in de Behandeling Van Winterdepressie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- SIGH SAD depression observer rating
研究概览
简要总结
One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms. Since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat SAD. In chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. In the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients., The investigators hypothesise that blue- enriched light improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65;
- •diagnosis of Seasonal affective Disorder, winter type according to DSM-IV;
- •SIGH SAD rating higher then or equal to 18 on day 1;
- •no other treatments for mood disorder during the study
- •stay in the Netherlands during the study
排除标准
- •other Axis 1 disorder according to DSM-IV
- •acute suicide risk
- •use of psychotropic drugs or photosensitizing drugs
- •eye diseases other then usual effect of aging
- •diabetes or epilepsy
- •regular shift work
结局指标
主要结局
SIGH SAD depression observer rating
时间窗: days 1, 8, 15, 22
次要结局
- selfrating of depressive mood(once daily during 22 days)
