Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg depression rating scale (MADRS)
研究概览
简要总结
This study evaluates the addition of light therapy with LUMINETTE device to usual treatment (antidepressant drug and psychotherapy) in the treatment of Major Depressive Disorder (MDD). Half of the participants will receive active light therapy with LUMINETTE device while the other half will receive placebo light therapy with LUMINETTE placebo device.
详细描述
Major depressive disorder (MDD) is a world wide spread disorder. According to the World health organization, MDD affects more than 300 million people of all ages in the world. Treatments of MDD include pharmacological treatment and psychotherapy. Pharmacological treatments, mostly serotonin selective reuptake inhibitors, have a delayed onset of action, require long-term treatment and have partial efficacy. In fact, only one third of patients respond to the first antidepressant treatment and two-third after multiple trials. So, there is a need for new treatment strategy.
Light therapy is a well established non pharmacological treatment of seasonal affective disorder, a clinical subtype of affective disorder characterized by recurrent episodes of depression occurring with a seasonal pattern. Patients are exposed to artificial light for a variable duration and intensity. Although the precise mechanism of bright light therapy remains unknown, it is thought to act through the eyes by activating the suprachiasmatic nucleus, the principal circadian pacemaker.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders I-V (DSM-IV), assessed by means of the Mini Neuropsychiatric International Interview (MINI).
- •age between 18 and 60 years.
- •affiliation with a welfare scheme.
- •complete information on the study received and written informed consent signed
排除标准
- •diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder) according to Axis I of the DSM-IV, assessed by means of the MINI.
- •absence of routine care for MDD.
- •previous or current LT treatment.
- •seasonal affective disorder.
- •high suicide risk, assessed by means of the MINI
- •ongoing neurological disease.
- •retinal pathology.
- •participation in another study.
- •patient impairment leading to difficulty participating or impossibility or inability to understand the information provided on the study.
- •persons cited in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code: pregnant women, parturient or breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under duress, persons admitted to a health or social establishment for other goals than research, minors, adults subject to a legal protection, adults who are unable to express their consent and who are not subject to a legal protection measure.
研究组 & 干预措施
active light therapy
Light therapy 1000 lux daily for 30 minutes, as soon as possible after awaking, in preference between 7 and 9 a.m., during 8 weeks in addition to usual treatment
干预措施: active light therapy (LUMINETTE®) (Device)
placebo light therapy
People receive usual treatment and use a placebo light therapy device (175 lux) daily for 30 minutes, as soon as possible after awaking, in preference between 7 and 9 a.m. during 8 weeks.
干预措施: placebo light therapy (Device)
结局指标
主要结局
Montgomery-Åsberg depression rating scale (MADRS)
时间窗: week 8
Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(week 8)
- Hamilton Anxiety Rating Scale (HAM-A)(week 8)
- Epworth Sleepiness Scale (ESS)(week 8)