Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21)
研究概览
简要总结
In a 3 years longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. The primary aim of the present study is to systematically explore and characterize risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of potential markers during the perinatal period (Life-ON study). Secondary aims are to explore the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3).
The characterization of specific predictive and risk factors for PND may substantially contribute to improve preventive medical and social strategies for the affected women. The study results are expected to promote a better understanding of the relationship between sleep disorders and the development of PND and to confirm, in a large sample of women, the safety and efficacy of BLT both in prevention and treatment of PND.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Medically healthy
- •Normal ocular function
- •Gestational age between 10 to 15 weeks at time of screening
- •Written informed consent
排除标准
- •Diagnosis of bipolar I or II disorder (DSM-5)
- •Recent history (less than 6 months) or current major depression or an Edinburgh Postnatal Depression Scale (EPDS) score > 12 at time of inclusion
- •Any psychotic episode, substance abuse, recent history of suicide attempt (less than 12 months)
- •Use of antidepressants or other pharmacologic treatments for depression in the last 6 months
- •Fetal malformations and intrauterine fetal death
结局指标
主要结局
Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21)
时间窗: during 6 weeks of light treatment plus 12 months observation
Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: during 6 weeks of light treatment plus 12 months observation
Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: during 6 weeks of light treatment plus 12 months observation
次要结局
- Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy(observation over a period of 2 years)
- Number of participants with treatment-related adverse events as assessed by the Systematic Assessment for Treatment Emergent Events (SAFTEE)(during 6 weeks of light treatment plus 12 months observation)
- Analysis of genetic risk factors for perinatal depression by single blood test(at 23th-25th week of gestation)
- Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography(at 23th-25th week of gestation)
- Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)(during 6 weeks of light treatment plus 12 months observation)
研究者
Mauro Manconi
Dr. med. Mauro Manconi
Ospedale Regionale di Lugano