DepressionNCT02664467
Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
A study testing Philips EnergyUp EnergyLight HF3419/01 in people with Depression and Depression, Postpartum, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression, Postpartum, Depressive Disorder
- What is being tested?
- Philips EnergyUp EnergyLight HF3419/01
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy
- Normal ocular function
- Gestational age between 10 to 15 weeks at time of screening
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neurocenter of Southern Switzerland
Lugano, Canton Ticino, 6900
About this study
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.
- Conditions
- Depression, Depression, Postpartum, Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Pregnancy Complications
- Being tested
- Philips EnergyUp EnergyLight HF3419/01
- Medical subject headings
- Depression, Depression, Postpartum, Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Pregnancy Complications, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips EnergyUp EnergyLight HF3419/01Device
Bright light therapy (10'000 lux) for 60 minutes after wake-up
Philips EnergyUp EnergyLight HF3419/01Device
Placebo dim light (500 lux) for 60 minutes after wake-up
| Study group | Role | What they receive |
|---|---|---|
| Bright light therapy (BLT) | Experimental | Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01 Receives: Device: Philips EnergyUp EnergyLight HF3419/01 |
| Placebo dim light | Placebo comparator | Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01 Receives: Device: Philips EnergyUp EnergyLight HF3419/01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Measured: 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)
Measured: during 6 weeks of light treatment plus 12 months observation
Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: during 6 weeks of light treatment plus 12 months observation
Secondary outcomes (5)
Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography
Measured: at 23th-25th week of gestation
Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy
Measured: observation over a period of 2 years
Analysis of genetic risk factors for perinatal depression by single blood test
Measured: at 23th-25th week of gestation
Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)
Measured: 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)
Measured: during 6 weeks of light treatment plus 12 months observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2018
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Lugano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, University of Milan, University of Turin, Italy
- Responsible party
- Principal investigator, Mauro Manconi, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664467
- Sponsor's protocol ID
- ORLugano
- Status last verified
- Mar 2021
- First submitted
- 13 Jan 2016
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35876837Baiardi 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.
PubMed 27814712
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
- ClinicalTrials.gov ID
- NCT02664467
- Acronym / sponsor ID
- ORLugano
- Conditions
- Depression, Depression, Postpartum, Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Ospedale Regionale di LuganoUniversity, hospital or other
- Collaborators
- University of Bologna, University of Milan, University of Turin, Italy
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy (BLT) | Experimental | Device: Philips EnergyUp EnergyLight HF3419/01Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01 |
| Placebo dim light | Placebo comparator | Device: Philips EnergyUp EnergyLight HF3419/01Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medically healthy
- Normal ocular function
- Gestational age between 10 to 15 weeks at time of screening
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips EnergyUp EnergyLight HF3419/01Bright light therapy (10'000 lux) for 60 minutes after wake-up | Device | Bright light therapy (BLT) |
| Philips EnergyUp EnergyLight HF3419/01Placebo dim light (500 lux) for 60 minutes after wake-up | Device | Placebo dim light |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 35876837Garbazza 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.
- Derived from this study: PubMed 27814712Baiardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips EnergyUp EnergyLight HF3419/01 in people with Depression and Depression, Postpartum, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664467, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.