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临床试验/NCT00006172
NCT00006172已完成不适用

Light and Negative Ion Treatment for Chronic Depression

New York State Psychiatric Institute3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2000年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
3
主要终点
Depression scale score

研究概览

简要总结

This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision.

详细描述

Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter) depression, but their effectiveness in treating chronic depression has not been explored.

Participants in this 10-week study will have an interview, a complete physical exam, and six one-hour appointments for progress evaluations. They will be randomly assigned to either light or high- or low-dose negative ions. Each treatment must be taken consistently for five weeks at the same time every day, after which treatment is temporarily suspended to determine whether symptoms return. Participants will then have the opportunity to try the alternate active treatment to determine which works best for them. On two occasions, participants will provide saliva samples, used to determine the level of melatonin, a hormone that becomes active at night and indicates whether a person's internal circadian clock is "in sync" with the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet readily available in medical practice, provides our research participants with unique information that can be used to optimize the timing of future treatment.

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 (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

入选标准

  • Diagnosis of major depression
  • Must be able to maintain a regular sleep schedule

排除标准

  • Depression restricted to certain seasons of the year
  • Presence of other psychiatric disorders
  • Current use of psychotropic medication, except for selective serotonin reuptake inhibitors (SSRIs)
  • Current use of recreational drugs or supplements that may affect mood
  • Current medical illness or medication that may affect response to antidepressant treatment
  • Long-distance travel while participating in the program
  • Pregnancy

结局指标

主要结局

Depression scale score

时间窗: 5 weeks

change in score relative to baseline

次要结局

  • pineal melatonin onset tme(5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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