Depression, Depression, Postpartum, Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Pregnancy Complications, Puerperal Disorders
Conditions
Brief summary
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.
Interventions
DEVICEPhilips EnergyUp EnergyLight HF3419/01
Bright light therapy (10'000 lux) for 60 minutes after wake-up
Sponsors
University of Bologna
University of Milan
University of Turin, Italy
Ospedale Regionale di Lugano
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS) | 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 | at 23th-25th week of gestation |
| 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed