Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
研究概览
简要总结
Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- •The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
- •The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
- •The 21-item Hamilton Depression Rating Scale score ≥ 10
- •The 8-item atypical symptom score ≥ 5
- •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
- •patients has some unstable somatic disorder
- •patient uses some 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 via ear canals during the current episode
结局指标
主要结局
The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
时间窗: At the end of the four-week study period
Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
次要结局
- ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD(At the end of the four-week study period)
- ≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score(At the end of the four-week study period)
- ≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score(At the end of the four-week study period)
- ≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score(At the end of the four-week study period)
- A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability(During the four week study period)