An interventional study of Philips EnergyUp EnergyLight HF3419/01 and Philips EnergyUp EnergyLight HF3419/01 in Depression, Depression, Postpartum and Depressive Disorder, sponsored by Ospedale Regionale di Lugano. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Ospedale Regionale di Lugano · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 450 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Ospedale Regionale di Lugano is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01
Device: Philips EnergyUp EnergyLight HF3419/01
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
Placebo dim light (500 lux) for 60 minutes after wake-up
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
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
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
Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography
Time frame: at 23th-25th week of gestation
Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy
Time frame: observation over a period of 2 years
Analysis of genetic risk factors for perinatal depression by single blood test
Time frame: at 23th-25th week of gestation
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
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
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Ospedale Regionale di Lugano