NCT01030276Unknown不适用
Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Remission as defined by the SIGH-SAD
研究概览
简要总结
The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- •HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
- •patient is over 18 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 DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
- •patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
- •patient has alcohol or some other substance use dependence or misuse
- •life-time suicide attempt, or any thought of suicide during the last month
- •patients has some unstable somatic disorder
- •patient uses some medication on regular basis
- •patient uses some herbal 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 had bright light therapy during the current episode
- •patient has some eye disease (patient can, however, be myopic or hyperopic)
结局指标
主要结局
Remission as defined by the SIGH-SAD
时间窗: 28 (visit window from 26 to 30 days) days after the inclusion day
次要结局
- Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21(28 (visit window from 26 to 30 days) days)
研究者
研究点 (2)
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