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

Sponsor

Ospedale Regionale di Lugano (Other)

Overall Status

Completed

CT.gov ID

NCT02664467

Collaborator

University of Bologna (Other), University of Milan (Other), University of Turin, Italy (Other)

450

Enrollment

Location

Arms

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Depression, Postpartum Depressive Disorder Depressive Disorder, Major Mood Disorders Pregnancy Complications Puerperal Disorders	Device: Philips EnergyUp EnergyLight HF3419/01 Device: Philips EnergyUp EnergyLight HF3419/01	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

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
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 Placebo dim light (500 lux) for 60 minutes after wake-up

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

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

Placebo dim light (500 lux) for 60 minutes after wake-up

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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