Depression, PostpartumNCT06246214
From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health
A study testing Blue Light Therapy in people with Depression, Postpartum and Anxiety State, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Anxiety State
- What is being tested?
- Blue Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jan 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4-6 weeks postpartum;
- Postnatal depression confirmed through Edinburgh Postnatal Depression Scale (EPDS) \> 10;
- Mini-International Neuropsychiatric Interview (M.I.N.I.) positive for current depressive episode.
Who cannot join
- Active suicidal ideation;
- Psychotic symptoms;
- Unstable general medical conditions that interfere with the acquisition of actigraphy;
- Newborn with severe health conditions (hospitalization, care in the neonatal ICU).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90410-000
Maria Paz L Hidalgo, 5533596339, mhidalgo@hcpa.edu.br
Maria Paz L Hidalgo
About this study
Official title: Innovations in Biological Rhythms in the Context of Mental Health: Effectiveness of New Technologies and Exposure to Different Lighting Patterns in Women During the Postpartum Period
Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.
Read the detailed description
Depression and anxiety during pregnancy and the postnatal period are major public health concerns, particularly in low and middle-income settings. Alterations in biological rhythms, sleep disturbances, and reduced exposure to daylight have been associated with increased risk for these conditions. The perinatal period represents a unique model of circadian misalignment vulnerability, driven by specific challenges to the temporal organization of physiological and behavioral rhythms. Prior evidence indicates that increased sleep onset latency and sleep deficits elevate the risk of postnatal depression, with sleep disturbances being among the most prominent risk factors and associated with up to a four-fold increase in depression risk.
Emerging findings suggest that changes in circadian health indicators, including sleep patterns, rest-activity rhythms, and light exposure, play a significant role in mood regulation during the peripartum period. Chronobiological interventions may therefore represent promising strategies for both prevention and treatment.
This Randomised Clinical Trial (RCT) aims to evaluate the effectiveness of Blue Light Therapy (BlueLT) for reducing depressive symptoms in women with postpartum depression and to assess whether alignment between rest-activity rhythms and internal body time mediates treatment effects. Chronobiological measures will include rest-activity rhythms, light exposure patterns, temperature rhythms, sleep duration and timing, social jetlag, and the BodyTime assay (single blood sample).
Participants with postpartum depression will be randomly assigned to either the BlueLT intervention or placebo light therapy (ControlLT). The BlueLT device delivers short-wavelength, narrow-band LED light (λp ~470 nm), while the ControlLT device emits dim, long-wavelength-enriched light. All participants in both groups will use the assigned light device for 30 minutes each day before 16:00 (4 p.m.) for 30 consecutive days.
The trial will enroll 50 women with postpartum depression (25 in the BlueLT group and 25 in the ControlLT group) and an additional 100 healthy postpartum controls from the same cohort. This healthy control group will serve as a comparator for circadian changes unrelated to depressive symptoms or treatment/placebo effects, acknowledging that pregnancy and postpartum adaptations may independently affect circadian phase relationships.
Exclusion criteria include: history of major depressive or anxiety disorder; current psychotic disorder; night-shift work; active suicidal ideation or psychotic symptoms; unstable medical conditions interfering with actigraphy; and newborns with severe health conditions.
- Conditions
- Depression, Postpartum, Anxiety State
- Being tested
- Blue Light Therapy, ControlLT
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Light TherapyDevice
The BlueLT device is equipped with a narrow band short wavelength Light Emitting Diode (LED) - wavelength peak(λp) of ~470 nm (blue).
ControlLTDevice
The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.
| Study group | Role | What they receive |
|---|---|---|
| BlueLT | Active comparator | Participants with depressive and/or anxiety symptoms that will receive the interventional light (BlueLT) Receives: Device: Blue Light Therapy |
| ControlLT | Sham comparator | Participants with depressive and/or anxiety symptoms that will receive the placebo light (ControlLT) Receives: Device: ControlLT |
| Healthy control | No intervention | Participants without depressive and/or anxiety symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The EDPS was developed to identify women who may have postpartum depression. This scale consists of 10 short statements. The participant checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. Items 3, 5 to 10 are reverse scored (i.e., 3, 2, 1, and 0). The total score is found by adding together the scores for each of the 10 items. A total score higher than 10 indicate the presence of depressive symptoms. A reduction in depressive symptoms clinically significant (outcome measure) will consist in a minimum difference of 4 points on the EPDS.
Measured: From enrollment to the end of treatment at 4 weeks
Anxiety symptoms
The General Anxiety Disorder 7-item scale (GAD-7) is one of the tools used to screen for anxiety or to measure its severity. Total score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Ranging from 0 to 21, the following threshold were previously proposed: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety). A reduction in anxiety symptoms clinically significant (outcome measure) will consist in a minimum difference of 4 points on the GAD-7.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start4 Jan 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Maria Paz L Hidalgo, Principal investigator, +555133596339
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246214
- Sponsor's protocol ID
- 2022-0584
- Status last verified
- Nov 2025
- First submitted
- 30 Jan 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tonon AC, Constantino DB, Amando GR, Abreu AC, Francisco AP, de Oliveira MAB, Pilz LK, Xavier NB, Rohrsetzer F, Souza L, Piccin J, Caye A, Petresco S, Manfro PH, Pereira R, Martini T, Kohrt BA, Fisher HL, Mondelli V, Kieling C, Hidalgo MPL. Sleep disturbances, circadian activity, and nocturnal light exposure characterize high risk for and current depression in adolescence. Sleep. 2022 Jul 11;45(7):zsac104. doi: 10.1093/sleep/zsac104.
PubMed 35522984Roenneberg T, Foster RG, Klerman EB. The circadian system, sleep, and the health/disease balance: a conceptual review. J Sleep Res. 2022 Aug;31(4):e13621. doi: 10.1111/jsr.13621. Epub 2022 Jun 7.
PubMed 35670313Hidalgo MP, Caumo W, Posser M, Coccaro SB, Camozzato AL, Chaves ML. Relationship between depressive mood and chronotype in healthy subjects. Psychiatry Clin Neurosci. 2009 Jun;63(3):283-90. doi: 10.1111/j.1440-1819.2009.01965.x.
PubMed 19566758Xavier NB, Abreu ACVO, Amando GR, Steibel EG, Pilz LK, Freitas JJ, da Silveira Cruz-Machado S, Markus RP, Frey BN, Hidalgo MP. Chronobiological parameters as predictors of early treatment response in major depression. J Affect Disord. 2023 Feb 15;323:679-688. doi: 10.1016/j.jad.2022.12.002. Epub 2022 Dec 5.
PubMed 36481230Kramer A, Lange T, Spies C, Finger AM, Berg D, Oster H. Foundations of circadian medicine. PLoS Biol. 2022 Mar 24;20(3):e3001567. doi: 10.1371/journal.pbio.3001567. eCollection 2022 Mar.
PubMed 35324893Krawczak EM, Minuzzi L, Simpson W, Hidalgo MP, Frey BN. Sleep, daily activity rhythms and postpartum mood: A longitudinal study across the perinatal period. Chronobiol Int. 2016;33(7):791-801. doi: 10.3109/07420528.2016.1167077. Epub 2016 Apr 20.
PubMed 27097327Slyepchenko A, Minuzzi L, Reilly JP, Frey BN. Longitudinal Changes in Sleep, Biological Rhythms, and Light Exposure From Late Pregnancy to Postpartum and Their Impact on Peripartum Mood and Anxiety. J Clin Psychiatry. 2022 Jan 18;83(2):21m13991. doi: 10.4088/JCP.21m13991.
PubMed 35044728Pilz LK, Carissimi A, Francisco AP, Oliveira MAB, Slyepchenko A, Epifano K, Garay LLS, Fabris RC, Scop M, Streiner DL, Hidalgo MP, Frey BN. Prospective Assessment of Daily Patterns of Mood-Related Symptoms. Front Psychiatry. 2018 Aug 21;9:370. doi: 10.3389/fpsyt.2018.00370. eCollection 2018.
PubMed 30186188Pilz LK, Keller LK, Lenssen D, Roenneberg T. Time to rethink sleep quality: PSQI scores reflect sleep quality on workdays. Sleep. 2018 May 1;41(5). doi: 10.1093/sleep/zsy029.
PubMed 29420828Pilz LK, Carissimi A, Oliveira MAB, Francisco AP, Fabris RC, Medeiros MS, Scop M, Frey BN, Adan A, Hidalgo MP. Rhythmicity of Mood Symptoms in Individuals at Risk for Psychiatric Disorders. Sci Rep. 2018 Jul 30;8(1):11402. doi: 10.1038/s41598-018-29348-z.
PubMed 30061722Constantino DB, Xavier NB, Levandovski R, Roenneberg T, Hidalgo MP, Pilz LK. Relationship Between Circadian Strain, Light Exposure, and Body Mass Index in Rural and Urban Quilombola Communities. Front Physiol. 2022 Jan 26;12:773969. doi: 10.3389/fphys.2021.773969. eCollection 2021.
PubMed 35153809Pilz LK, Xavier NB, Levandovski R, Oliveira MAB, Tonon AC, Constantino DB, Machado V, Roenneberg T, Hidalgo MP. Circadian Strain, Light Exposure, and Depressive Symptoms in Rural Communities of Southern Brazil. Front Netw Physiol. 2022 Jan 26;1:779136. doi: 10.3389/fnetp.2021.779136. eCollection 2021.
PubMed 36925579Pilz LK, de Oliveira MAB, Steibel EG, Policarpo LM, Carissimi A, Carvalho FG, Constantino DB, Tonon AC, Xavier NB, da Rosa Righi R, Hidalgo MP. Development and testing of methods for detecting off-wrist in actimetry recordings. Sleep. 2022 Aug 11;45(8):zsac118. doi: 10.1093/sleep/zsac118.
PubMed 35598321Comiran Tonon A, Pilz LK, Amando GR, Constantino DB, Boff Borges R, Caye A, Rohrsetzer F, Souza L, Fisher HL, Kohrt BA, Mondelli V, Kieling C, Idiart M, Diez-Noguera A, Hidalgo MP. Handling missing data in rest-activity time series measured by actimetry. Chronobiol Int. 2022 Jul;39(7):964-975. doi: 10.1080/07420528.2022.2051714. Epub 2022 Mar 30.
PubMed 35350931Levandovski R, Dantas G, Fernandes LC, Caumo W, Torres I, Roenneberg T, Hidalgo MP, Allebrandt KV. Depression scores associate with chronotype and social jetlag in a rural population. Chronobiol Int. 2011 Nov;28(9):771-8. doi: 10.3109/07420528.2011.602445. Epub 2011 Sep 6.
PubMed 21895489
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in Biological Rhythms in the Context of Mental Health: Effectiveness of New Technologies and Exposure to Different Lighting Patterns in Women During the Postpartum Period
- ClinicalTrials.gov ID
- NCT06246214
- Acronym / sponsor ID
- 2022-0584
- Conditions
- Depression, Postpartum, Anxiety State
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- 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.
Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.
Detailed description
Depression and anxiety during pregnancy and the postnatal period are major public health concerns, particularly in low and middle-income settings. Alterations in biological rhythms, sleep disturbances, and reduced exposure to daylight have been associated with increased risk for these conditions. The perinatal period represents a unique model of circadian misalignment vulnerability, driven by specific challenges to the temporal organization of physiological and behavioral rhythms. Prior evidence indicates that increased sleep onset latency and sleep deficits elevate the risk of postnatal depression, with sleep disturbances being among the most prominent risk factors and associated with up to a four-fold increase in depression risk.
Emerging findings suggest that changes in circadian health indicators, including sleep patterns, rest-activity rhythms, and light exposure, play a significant role in mood regulation during the peripartum period. Chronobiological interventions may therefore represent promising strategies for both prevention and treatment.
This Randomised Clinical Trial (RCT) aims to evaluate the effectiveness of Blue Light Therapy (BlueLT) for reducing depressive symptoms in women with postpartum depression and to assess whether alignment between rest-activity rhythms and internal body time mediates treatment effects. Chronobiological measures will include rest-activity rhythms, light exposure patterns, temperature rhythms, sleep duration and timing, social jetlag, and the BodyTime assay (single blood sample).
Participants with postpartum depression will be randomly assigned to either the BlueLT intervention or placebo light therapy (ControlLT). The BlueLT device delivers short-wavelength, narrow-band LED light (λp ~470 nm), while the ControlLT device emits dim, long-wavelength-enriched light. All participants in both groups will use the assigned light device for 30 minutes each day before 16:00 (4 p.m.) for 30 consecutive days.
The trial will enroll 50 women with postpartum depression (25 in the BlueLT group and 25 in the ControlLT group) and an additional 100 healthy postpartum controls from the same cohort. This healthy control group will serve as a comparator for circadian changes unrelated to depressive symptoms or treatment/placebo effects, acknowledging that pregnancy and postpartum adaptations may independently affect circadian phase relationships.
Exclusion criteria include: history of major depressive or anxiety disorder; current psychotic disorder; night-shift work; active suicidal ideation or psychotic symptoms; unstable medical conditions interfering with actigraphy; and newborns with severe health conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BlueLT | Active comparator | Device: Blue Light TherapyParticipants with depressive and/or anxiety symptoms that will receive the interventional light (BlueLT) |
| ControlLT | Sham comparator | Device: ControlLTParticipants with depressive and/or anxiety symptoms that will receive the placebo light (ControlLT) |
| Healthy control | No intervention | –Participants without depressive and/or anxiety symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 4-6 weeks postpartum;
- Postnatal depression confirmed through Edinburgh Postnatal Depression Scale (EPDS) \> 10;
- Mini-International Neuropsychiatric Interview (M.I.N.I.) positive for current depressive episode.
Key exclusion criteria (4 listed)
- Active suicidal ideation;
- Psychotic symptoms;
- Unstable general medical conditions that interfere with the acquisition of actigraphy;
- Newborn with severe health conditions (hospitalization, care in the neonatal ICU).
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 |
|---|---|---|
| Blue Light TherapyThe BlueLT device is equipped with a narrow band short wavelength Light Emitting Diode (LED) - wavelength peak(λp) of ~470 nm (blue). | Device | BlueLT |
| ControlLTThe ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED. | Device | ControlLT |
Primary outcome
Depressive symptoms
Time frame: From enrollment to the end of treatment at 4 weeks
The EDPS was developed to identify women who may have postpartum depression. This scale consists of 10 short statements. The participant checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. Items 3, 5 to 10 are reverse scored (i.e., 3, 2, 1, and 0). The total score is found by adding together the scores for each of the 10 items. A total score higher than 10 indicate the presence of depressive symptoms. A reduction in depressive symptoms clinically significant (outcome measure) will consist in a minimum difference of 4 points on the EPDS.
Anxiety symptoms
Time frame: From enrollment to the end of treatment at 4 weeks
The General Anxiety Disorder 7-item scale (GAD-7) is one of the tools used to screen for anxiety or to measure its severity. Total score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Ranging from 0 to 21, the following threshold were previously proposed: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety). A reduction in anxiety symptoms clinically significant (outcome measure) will consist in a minimum difference of 4 points on the GAD-7.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 35522984Tonon AC, Constantino DB, Amando GR, Abreu AC, Francisco AP, de Oliveira MAB, Pilz LK, Xavier NB, Rohrsetzer F, Souza L, Piccin J, Caye A, Petresco S, Manfro PH, Pereira R, Martini T, Kohrt BA, Fisher HL, Mondelli V, Kieling C, Hidalgo MPL. Sleep disturbances, circadian activity, and nocturnal light exposure characterize high risk for and current depression in adolescence. Sleep. 2022 Jul 11;45(7):zsac104. doi: 10.1093/sleep/zsac104.
- Background: PubMed 35670313Roenneberg T, Foster RG, Klerman EB. The circadian system, sleep, and the health/disease balance: a conceptual review. J Sleep Res. 2022 Aug;31(4):e13621. doi: 10.1111/jsr.13621. Epub 2022 Jun 7.
- Background: PubMed 19566758Hidalgo MP, Caumo W, Posser M, Coccaro SB, Camozzato AL, Chaves ML. Relationship between depressive mood and chronotype in healthy subjects. Psychiatry Clin Neurosci. 2009 Jun;63(3):283-90. doi: 10.1111/j.1440-1819.2009.01965.x.
- Background: PubMed 36481230Xavier NB, Abreu ACVO, Amando GR, Steibel EG, Pilz LK, Freitas JJ, da Silveira Cruz-Machado S, Markus RP, Frey BN, Hidalgo MP. Chronobiological parameters as predictors of early treatment response in major depression. J Affect Disord. 2023 Feb 15;323:679-688. doi: 10.1016/j.jad.2022.12.002. Epub 2022 Dec 5.
- Background: PubMed 35324893Kramer A, Lange T, Spies C, Finger AM, Berg D, Oster H. Foundations of circadian medicine. PLoS Biol. 2022 Mar 24;20(3):e3001567. doi: 10.1371/journal.pbio.3001567. eCollection 2022 Mar.
- Background: PubMed 27097327Krawczak EM, Minuzzi L, Simpson W, Hidalgo MP, Frey BN. Sleep, daily activity rhythms and postpartum mood: A longitudinal study across the perinatal period. Chronobiol Int. 2016;33(7):791-801. doi: 10.3109/07420528.2016.1167077. Epub 2016 Apr 20.
- Background: PubMed 35044728Slyepchenko A, Minuzzi L, Reilly JP, Frey BN. Longitudinal Changes in Sleep, Biological Rhythms, and Light Exposure From Late Pregnancy to Postpartum and Their Impact on Peripartum Mood and Anxiety. J Clin Psychiatry. 2022 Jan 18;83(2):21m13991. doi: 10.4088/JCP.21m13991.
- Background: PubMed 30186188Pilz LK, Carissimi A, Francisco AP, Oliveira MAB, Slyepchenko A, Epifano K, Garay LLS, Fabris RC, Scop M, Streiner DL, Hidalgo MP, Frey BN. Prospective Assessment of Daily Patterns of Mood-Related Symptoms. Front Psychiatry. 2018 Aug 21;9:370. doi: 10.3389/fpsyt.2018.00370. eCollection 2018.
- Background: PubMed 29420828Pilz LK, Keller LK, Lenssen D, Roenneberg T. Time to rethink sleep quality: PSQI scores reflect sleep quality on workdays. Sleep. 2018 May 1;41(5). doi: 10.1093/sleep/zsy029.
- Background: PubMed 30061722Pilz LK, Carissimi A, Oliveira MAB, Francisco AP, Fabris RC, Medeiros MS, Scop M, Frey BN, Adan A, Hidalgo MP. Rhythmicity of Mood Symptoms in Individuals at Risk for Psychiatric Disorders. Sci Rep. 2018 Jul 30;8(1):11402. doi: 10.1038/s41598-018-29348-z.
- Background: PubMed 35153809Constantino DB, Xavier NB, Levandovski R, Roenneberg T, Hidalgo MP, Pilz LK. Relationship Between Circadian Strain, Light Exposure, and Body Mass Index in Rural and Urban Quilombola Communities. Front Physiol. 2022 Jan 26;12:773969. doi: 10.3389/fphys.2021.773969. eCollection 2021.
- Background: PubMed 36925579Pilz LK, Xavier NB, Levandovski R, Oliveira MAB, Tonon AC, Constantino DB, Machado V, Roenneberg T, Hidalgo MP. Circadian Strain, Light Exposure, and Depressive Symptoms in Rural Communities of Southern Brazil. Front Netw Physiol. 2022 Jan 26;1:779136. doi: 10.3389/fnetp.2021.779136. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Maria Paz L Hidalgo principal investigator
+555133596339
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Light Therapy in people with Depression, Postpartum and Anxiety State, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Paz L Hidalgo (+555133596339, mhidalgo@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 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 NCT06246214, which also lists 18 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 3 Dec 2025.