Perinatal DepressionPsyCOVIDUMGENNCT05175755
Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
A study testing Patients in people with Perinatal Depression, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Sep 2023to 31 Dec 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant woman whose age is ≥ 18 years, delivering after 34 SA in one of the two participating maternity hospitals that responded to the EPDS
- Accepting a blood sample
- EPDS score less than 8 or greater than 11
- French-speaking woman
- Woman affiliated with a health insurance plan
- Free, informed, written consent was obtained from the woman
Who cannot join
- Fetal death or medical termination of pregnancy
- Women under guardianship or trusteeship
- Woman deprived of liberty
- Woman under court protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternité Louis Mourier
Colombes, 92700
Caroline DUBERTRET, MD
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Elie P AZRIA
About this study
In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences.
Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression.
Read more
In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals.
This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.
- Conditions
- Perinatal Depression
- Being tested
- Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsOther
The procedure involves taking a total of 12 ml of blood.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | The procedure involves taking a total of 12 ml of blood. Receives: Other: Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of genetic factors involved in maternally diagnosed perinatal depression by genome-wide association analysis
This outcome corresponds to the biobank built up from the blood samples of the included female volunteers.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start25 Sep 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perinatal 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie AZRIA, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175755
- Sponsor's protocol ID
- PsyCOVIDUMGEN
- Acronym
- PsyCOVIDUMGEN
- Status last verified
- Feb 2023
- First submitted
- 30 Dec 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12.
PubMed 32151335Kayem G, Lecarpentier E, Deruelle P, Bretelle F, Azria E, Blanc J, Bohec C, Bornes M, Ceccaldi PF, Chalet Y, Chauleur C, Cordier AG, Desbriere R, Doret M, Dreyfus M, Driessen M, Fermaut M, Gallot D, Garabedian C, Huissoud C, Luton D, Morel O, Perrotin F, Picone O, Rozenberg P, Sentilhes L, Sroussi J, Vayssiere C, Verspyck E, Vivanti AJ, Winer N, Alessandrini V, Schmitz T. A snapshot of the Covid-19 pandemic among pregnant women in France. J Gynecol Obstet Hum Reprod. 2020 Sep;49(7):101826. doi: 10.1016/j.jogoh.2020.101826. Epub 2020 Jun 4.
PubMed 32505805Rasmussen SA, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and Pregnancy: Responding to a Rapidly Evolving Situation. Obstet Gynecol. 2020 May;135(5):999-1002. doi: 10.1097/AOG.0000000000003873.
PubMed 32213786Walker KF, O'Donoghue K, Grace N, Dorling J, Comeau JL, Li W, Thornton JG. Maternal transmission of SARS-COV-2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis. BJOG. 2020 Oct;127(11):1324-1336. doi: 10.1111/1471-0528.16362. Epub 2020 Jul 22.
PubMed 32531146Shigemura J, Ursano RJ, Morganstein JC, Kurosawa M, Benedek DM. Public responses to the novel 2019 coronavirus (2019-nCoV) in Japan: Mental health consequences and target populations. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-282. doi: 10.1111/pcn.12988. Epub 2020 Feb 23. No abstract available.
PubMed 32034840Achtyes E, Keaton SA, Smart L, Burmeister AR, Heilman PL, Krzyzanowski S, Nagalla M, Guillemin GJ, Escobar Galvis ML, Lim CK, Muzik M, Postolache TT, Leach R, Brundin L. Inflammation and kynurenine pathway dysregulation in post-partum women with severe and suicidal depression. Brain Behav Immun. 2020 Jan;83:239-247. doi: 10.1016/j.bbi.2019.10.017. Epub 2019 Nov 5.
PubMed 31698012
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
- ClinicalTrials.gov ID
- NCT05175755
- Acronym / sponsor ID
- PsyCOVIDUMGEN / PsyCOVIDUMGEN
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jan 2022 (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.
In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences.
Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression.
In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals.
This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: PatientsThe procedure involves taking a total of 12 ml of blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant woman whose age is ≥ 18 years, delivering after 34 SA in one of the two participating maternity hospitals that responded to the EPDS
- Accepting a blood sample
- EPDS score less than 8 or greater than 11
- French-speaking woman
- Woman affiliated with a health insurance plan
Key exclusion criteria (4 listed)
- Fetal death or medical termination of pregnancy
- Women under guardianship or trusteeship
- Woman deprived of liberty
- Woman under court protection
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 |
|---|---|---|
| PatientsThe procedure involves taking a total of 12 ml of blood. | Other | Patients |
Primary outcome
Role of genetic factors involved in maternally diagnosed perinatal depression by genome-wide association analysis
Time frame: Day 3
This outcome corresponds to the biobank built up from the blood samples of the included female volunteers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32151335Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12.
- Background: PubMed 32505805Kayem G, Lecarpentier E, Deruelle P, Bretelle F, Azria E, Blanc J, Bohec C, Bornes M, Ceccaldi PF, Chalet Y, Chauleur C, Cordier AG, Desbriere R, Doret M, Dreyfus M, Driessen M, Fermaut M, Gallot D, Garabedian C, Huissoud C, Luton D, Morel O, Perrotin F, Picone O, Rozenberg P, Sentilhes L, Sroussi J, Vayssiere C, Verspyck E, Vivanti AJ, Winer N, Alessandrini V, Schmitz T. A snapshot of the Covid-19 pandemic among pregnant women in France. J Gynecol Obstet Hum Reprod. 2020 Sep;49(7):101826. doi: 10.1016/j.jogoh.2020.101826. Epub 2020 Jun 4.
- Background: PubMed 32213786Rasmussen SA, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and Pregnancy: Responding to a Rapidly Evolving Situation. Obstet Gynecol. 2020 May;135(5):999-1002. doi: 10.1097/AOG.0000000000003873.
- Background: PubMed 32531146Walker KF, O'Donoghue K, Grace N, Dorling J, Comeau JL, Li W, Thornton JG. Maternal transmission of SARS-COV-2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis. BJOG. 2020 Oct;127(11):1324-1336. doi: 10.1111/1471-0528.16362. Epub 2020 Jul 22.
- Background: PubMed 32034840Shigemura J, Ursano RJ, Morganstein JC, Kurosawa M, Benedek DM. Public responses to the novel 2019 coronavirus (2019-nCoV) in Japan: Mental health consequences and target populations. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-282. doi: 10.1111/pcn.12988. Epub 2020 Feb 23. No abstract available.
- Background: PubMed 31698012Achtyes E, Keaton SA, Smart L, Burmeister AR, Heilman PL, Krzyzanowski S, Nagalla M, Guillemin GJ, Escobar Galvis ML, Lim CK, Muzik M, Postolache TT, Leach R, Brundin L. Inflammation and kynurenine pathway dysregulation in post-partum women with severe and suicidal depression. Brain Behav Immun. 2020 Jan;83:239-247. doi: 10.1016/j.bbi.2019.10.017. Epub 2019 Nov 5.
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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.
Elie AZRIA, MD principal investigator
Fondation Hôpital Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients in people with Perinatal Depression, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elie AZRIA, MD (144127570 ext. +33, eazria@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of genetic factors involved in maternally diagnosed perinatal depression by genome-wide association analysis (time frame: Day 3). 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 NCT05175755, which also lists 7 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 21 Aug 2023.