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

Primary Purpose

Depression, Depression, Postpartum, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Philips EnergyUp EnergyLight HF3419/01
Philips EnergyUp EnergyLight HF3419/01
Sponsored by
Ospedale Regionale di Lugano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Neurocenter of Southern Switzerland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright light therapy (BLT)

Placebo dim light

Arm Description

Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01

Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01

Outcomes

Primary Outcome Measures

Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21)
Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography
Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy
Analysis of genetic risk factors for perinatal depression by single blood test
Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)
Number of participants with treatment-related adverse events as assessed by the Systematic Assessment for Treatment Emergent Events (SAFTEE)

Full Information

First Posted
January 13, 2016
Last Updated
March 3, 2021
Sponsor
Ospedale Regionale di Lugano
Collaborators
University of Bologna, University of Milan, University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02664467
Brief Title
Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
Official Title
Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Regionale di Lugano
Collaborators
University of Bologna, University of Milan, University of Turin, Italy

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression, Postpartum, Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Pregnancy Complications, Puerperal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright light therapy (BLT)
Arm Type
Experimental
Arm Description
Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01
Arm Title
Placebo dim light
Arm Type
Placebo Comparator
Arm Description
Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01
Intervention Type
Device
Intervention Name(s)
Philips EnergyUp EnergyLight HF3419/01
Intervention Description
Bright light therapy (10'000 lux) for 60 minutes after wake-up
Intervention Type
Device
Intervention Name(s)
Philips EnergyUp EnergyLight HF3419/01
Intervention Description
Placebo dim light (500 lux) for 60 minutes after wake-up
Primary Outcome Measure Information:
Title
Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
during 6 weeks of light treatment plus 12 months observation
Title
Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21)
Time Frame
during 6 weeks of light treatment plus 12 months observation
Title
Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
during 6 weeks of light treatment plus 12 months observation
Secondary Outcome Measure Information:
Title
Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography
Time Frame
at 23th-25th week of gestation
Title
Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy
Time Frame
observation over a period of 2 years
Title
Analysis of genetic risk factors for perinatal depression by single blood test
Time Frame
at 23th-25th week of gestation
Title
Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)
Time Frame
during 6 weeks of light treatment plus 12 months observation
Title
Number of participants with treatment-related adverse events as assessed by the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time Frame
during 6 weeks of light treatment plus 12 months observation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Neurocenter of Southern Switzerland
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27814712
Citation
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.
Results Reference
derived

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

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