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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Bright light therapy (10'000 lux) for 60 minutes after wake-up
Placebo dim light (500 lux) for 60 minutes after wake-up
Neurocenter of Southern Switzerland
Lugano, Canton Ticino, Switzerland
Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: during 6 weeks of light treatment plus 12 months observation
Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21)
Time frame: during 6 weeks of light treatment plus 12 months observation
Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: during 6 weeks of light treatment plus 12 months observation
Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography
Time frame: at 23th-25th week of gestation
Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy
Time frame: observation over a period of 2 years
Analysis of genetic risk factors for perinatal depression by single blood test
Time frame: at 23th-25th week of gestation
Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)
Time frame: during 6 weeks of light treatment plus 12 months observation
Number of participants with treatment-related adverse events as assessed by the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: during 6 weeks of light treatment plus 12 months observation
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