A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy For Seasonal Affective Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
研究概览
简要总结
The purpose is to study treatments of Seasonal Affective Disorder (SAD).
详细描述
This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.
This trial has now been completed.
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
- •Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.
排除标准
- •Significant suicidal risk
- •Serious medical illness
- •Pregnancy
- •Other DSM-IV diagnoses
- •Taking mood altering medication
- •May not travel to a sunny destination during study
结局指标
主要结局
Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
时间窗: Week 4
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression. Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization
次要结局
- SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version(Weekly following randomization)