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Completed

NCT Number: NCT02664467

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depression, Postpartum Depressive Disorder Depressive Disorder, Major Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6900, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Philips EnergyUp EnergyLight HF3419/01

Device

Bright light therapy (10'000 lux) for 60 minutes after wake-up

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ospedale Regionale di Lugano

Other

Collaborators

  • University of Bologna
  • University of Milan
  • University of Turin, Italy

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jan 27, 2016
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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