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

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ClinicalTrials.gov Identifier: NCT02664467
Recruitment Status : Unknown
Verified September 2016 by Mauro Manconi, Ospedale Regionale di Lugano.
Recruitment status was:  Recruiting
First Posted : January 27, 2016
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
University of Bologna
University of Milan
University of Turin, Italy
Information provided by (Responsible Party):
Mauro Manconi, Ospedale Regionale di Lugano

Study Description
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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 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Study Start Date : May 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography [ Time Frame: at 23th-25th week of gestation ]
  2. Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy [ Time Frame: observation over a period of 2 years ]
  3. Analysis of genetic risk factors for perinatal depression by single blood test [ Time Frame: at 23th-25th week of gestation ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664467


Contacts
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Contact: Mauro Manconi, MD, PhD +41 91 811 68 25 mauro.manconi@eoc.ch
Contact: Corrado Garbazza, MD +41 91 811 68 89 corrado.garbazza@eoc.ch

Locations
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Switzerland
Neurocenter of Southern Switzerland Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Mauro Manconi, MD, PhD    +41 91 811 68 25    mauro.manconi@eoc.ch   
Principal Investigator: Mauro Manconi, MD, PhD         
Sub-Investigator: Corrado Garbazza, MD         
Sub-Investigator: Silvia Riccardi, MD         
Sponsors and Collaborators
Ospedale Regionale di Lugano
University of Bologna
University of Milan
University of Turin, Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mauro Manconi, Dr. med. Mauro Manconi, Ospedale Regionale di Lugano
ClinicalTrials.gov Identifier: NCT02664467     History of Changes
Other Study ID Numbers: ORLugano
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Pregnancy Complications
Depression, Postpartum
Puerperal Disorders
Disease
Depression
Depressive Disorder
 Mood Disorders
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mental Disorders