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

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 Overview

• Status: Completed
• Conditions: Depressive Disorder; Depression; Mood Disorders; Pregnancy Complications; Depression, Postpartum; Puerperal Disorders; Depressive Disorder, Major
• Intervention / Treatment: Device: Philips EnergyUp EnergyLight HF3419/01; Device: Philips EnergyUp EnergyLight HF3419/01

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Neurocenter of Southern Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ospedale Regionale di Lugano
• Collaborators: University of Bologna; University of Turin, Italy; University of Milan

Publications and helpful links

General Publications

• Baiardi S, Cirignotta F, Cicolin A, Garbazza C, D'Agostino A, Gambini O, Giordano A, Canevini M, Zambrelli E, Marconi AM, Mondini S, Borgwardt S, Cajochen C, Rizzo N, Manconi M. Chronobiology, sleep-related risk factors and light therapy in perinatal depression: the "Life-ON" project. BMC Psychiatry. 2016 Nov 4;16(1):374. doi: 10.1186/s12888-016-1086-0.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Depression; Depressive Disorder; Disease; Depression, Postpartum; Mood Disorders; Depressive Disorder, Major; Pregnancy Complications; Puerperal Disorders
• Other Study ID Numbers: ORLugano