Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project

Study Overview
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Brief Summary
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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.

Official Title
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Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project

Conditions
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Depression, Depression, Postpartum, Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Pregnancy Complications, Puerperal Disorders

Intervention / Treatment
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* Device: Philips EnergyUp EnergyLight HF3419/01
* Device: Philips EnergyUp EnergyLight HF3419/01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically healthy Normal ocular function Gestational age between 10 to 15 weeks at time of screening Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright light therapy (BLT)<br>Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01 | Device: Philips EnergyUp EnergyLight HF3419/01<br>* Bright light therapy (10'000 lux) for 60 minutes after wake-up<br>|
| Placebo Comparator: Placebo dim light<br>Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01 | Device: Philips EnergyUp EnergyLight HF3419/01<br>* Placebo dim light (500 lux) for 60 minutes after wake-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS) |  | 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) |  | during 6 weeks of light treatment plus 12 months observation | 
| Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) |  | during 6 weeks of light treatment plus 12 months observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography |  | at 23th-25th week of gestation | 
| Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy |  | observation over a period of 2 years | 
| Analysis of genetic risk factors for perinatal depression by single blood test |  | 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 | 
| 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 |