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

Lugano Regional Hospital

Status

Completed

Conditions

Puerperal Disorders

Pregnancy Complications

Depression, Postpartum

Depressive Disorder, Major

Depression

Mood Disorders

Depressive Disorder

Treatments

Device: Philips EnergyUp EnergyLight HF3419/01

Study type

Interventional

Funder types

Other

Identifiers

NCT02664467

ORLugano

Details and patient eligibility

About

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.

Enrollment

450 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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