ChiCTR-IOR-15006937已完成不适用
輔助光治療對「夜晚型」抑鬱症患者的隨機對照計劃
Health Medical and Research Fund1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 1990年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- remission rate as defined by the HAM-D 17 score
研究概览
简要总结
輔助光治療對「夜晚型」抑鬱症患者
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Single
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Aged 18-65 years;
- •Is capable of giving informed consent;
- •Meet diagnostic criteria of major depressive disorder (MDD) by the Mini-Neuropsychiatric Interview (MINI);
- •Score at least 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17);
- •Evening chronotype.
排除标准
- •Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder);
- •A current diagnosis of substance abuse or dependence;
- •A current or past history of manic or hypomanic episode, schizophrenia, personality disorder, mental retardation, or organic mental disorder;
- •Significant risk of suicide in the opinion of the investigator, or has moderate or above level of suicidality as assessed in the MINI Suicidality Module, or has made a suicide attempt in the past three months;
- •History of light induced migraine/ epilepsy;
- •Current use of photosensitizing medications, e.g. St John's wart;
- •Presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma;
- •Drugs that may interfere with circadian rhythm, i.e. lithium, exogenous melatonin, melatonergic antidepressants within past 3 months;
- •Shift worker;
- •Trans-meridian flight in the past 3 months and during study;
- •Enrolment in any other clinical trial investigational products within one month at the entry of the study;
- •Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview.
研究组 & 干预措施
Two groups
Light therapy group will receive a 5-week daily light therapy. TAU subjects will also be prescribed with a 5-week placebo intervention.
结局指标
主要结局
remission rate as defined by the HAM-D 17 score
the depressive symptoms severity via Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)
次要结局
- anxiety symptoms (HAM-A, HADS)
- insomnia symptoms (ISI)
- suicidal ideation (BSSI)
- fatigue (CFS)
- quality of life (SF-36)
- sleep pattern
研究者
研究点 (1)
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