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临床试验/NCT00269633
NCT00269633已完成2 期

Optimizing Light Wavelength for Treatment of Seasonal Affective Disorder

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
9
试验地点
2
主要终点
Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks

研究概览

简要总结

The specific aim of this study is to test the hypothesis that light stimuli concentrated around 467 nm will evoke a significantly stronger therapeutic response in SAD patients compared to light stimuli concentrated around 657 nm at an equal photon density.

The secondary objective of this study is to determine the efficacy of different colors and levels of light in order to optimize therapeutic benefit, while also minimizing side effects and maintaining safety of light exposure.

详细描述

Studies report as many as 1 out of every 5 Americans is affected by mild to severe Seasonal Affective Disorder (SAD, winter depression). Although the exact cause of this condition is unknown, bright light has proven to be an effective therapeutic treatment for many people with SAD. The light sources that have been traditionally used for treatment of SAD produce white light with great variability in the balance of wavelengths that are emitted across the visible spectrum. Although several studies have attempted to test the effectiveness of different wavelengths for treatment of SAD, the devices used in those studies employed broad bandwidths of light. With the technological advancements in light emitting diodes (LEDs) the production of new light therapy equipment with much narrower bandwidths of light is possible. Side effects of exposure to traditional white light therapy for SAD have included hypomanic activation, irritability, headache, eyestrain and nausea. We hypothesize that when the wavelength of light therapy is optimized, it should be feasible to elicit strong therapeutic benefits with lower light intensities and fewer side effects. Previous studies, approved by the Jefferson IRB and successfully completed by our laboratory have shown that some colors of light are more effective in treating SAD than other colors.

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, Care Provider)

入排标准

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

入选标准

  • Clinical diagnosis of Seasonal Affective Disorder
  • Over 18 years old
  • Stable sleeping pattern with a bedtime no later than 1 a.m.

排除标准

  • Pregnant women
  • Concurrent psychiatric illness that would preclude compliance with the protocol
  • active suicidal or homicidal ideation or plan
  • variable psychiatric illness (i.e. rapid cycling disorder or severe premenstrual syndrome)
  • individuals with substance abuse or dependence who have not been in remission for at least one year
  • individuals taking photosensitizing medications
  • individuals with macular degeneration or other ocular conditions which might be adversely affected by light
  • less then six weeks after onset of psychotherapeutic treatment

结局指标

主要结局

Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks

时间窗: Averaged over Three Weeks During Treatment

Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.

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 (2)

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