Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
NCT ID: NCT02664467
Last Updated: 2021-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
450 participants
INTERVENTIONAL
2016-05-31
2020-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health
NCT06246214
Light Therapy for Depression During Pregnancy
NCT01043289
Sleep to Reduce Incident Depression Effectively in Peripartum
NCT06430333
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
NCT02769858
PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be
NCT07302165
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bright light therapy (BLT)
Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01
Philips EnergyUp EnergyLight HF3419/01
Bright light therapy (10'000 lux) for 60 minutes after wake-up
Placebo dim light
Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01
Philips EnergyUp EnergyLight HF3419/01
Placebo dim light (500 lux) for 60 minutes after wake-up
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Philips EnergyUp EnergyLight HF3419/01
Bright light therapy (10'000 lux) for 60 minutes after wake-up
Philips EnergyUp EnergyLight HF3419/01
Placebo dim light (500 lux) for 60 minutes after wake-up
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Normal ocular function
* Gestational age between 10 to 15 weeks at time of screening
* Written informed consent
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bologna
OTHER
University of Milan
OTHER
University of Turin, Italy
OTHER
Ospedale Regionale di Lugano
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mauro Manconi
Dr. med. Mauro Manconi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurocenter of Southern Switzerland
Lugano, Canton Ticino, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Garbazza C, Cirignotta F, D'Agostino A, Cicolin A, Hackethal S, Wirz-Justice A, Cajochen C, Manconi M; "Life-ON" study group. Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial. Acta Psychiatr Scand. 2022 Oct;146(4):350-356. doi: 10.1111/acps.13482. Epub 2022 Aug 3.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ORLugano
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.