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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664467
• Other study ID #: ORLugano
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 2020

Study information

• Verified date: March 2021
• Source: Ospedale Regionale di Lugano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Mood Disorders
• Pregnancy Complications
• Puerperal Disorders

Intervention

Device:
• Philips EnergyUp EnergyLight HF3419/01
Bright light therapy (10'000 lux) for 60 minutes after wake-up
• Philips EnergyUp EnergyLight HF3419/01
Placebo dim light (500 lux) for 60 minutes after wake-up

Locations

Country	Name	City	State
Switzerland	Neurocenter of Southern Switzerland	Lugano	Ticino

Sponsors (4)

Lead Sponsor	Collaborator
Ospedale Regionale di Lugano	University of Bologna, University of Milan, University of Turin, Italy

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)		during 6 weeks of light treatment plus 12 months observation
Primary	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
Primary	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	Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography		at 23th-25th week of gestation
Secondary	Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy		observation over a period of 2 years
Secondary	Analysis of genetic risk factors for perinatal depression by single blood test		at 23th-25th week of gestation
Secondary	Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)		during 6 weeks of light treatment plus 12 months observation
Secondary	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