Postpartum DepressionIGEDEPPNCT01648816
Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
An observational study of Postpartum Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- How many people
- 3,338 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2011to 20 Jul 2017
- Phase
- Observational
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: causasian mothers after pregnancy
Who may be able to join
- Caucasian mothers included after pregnancy (J0-J4)
Who cannot join
- Age <18 years old, schizophrenia or mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.
Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction)".
Read the detailed description
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.
Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction).
We want first to analyze the allelic association between SNPs of 5-HT, HPA and neurodevelopment genes and PPD with a case control association study We then analyse the interaction between maternal stressors during pregnancy and SNPS of our candidate genes (CRHR1, 5-HTT, TPH, BDNF, HMCN1).
3000 Caucasian mothers are included after pregnancy in 8 maternities and are evaluated at the inclusion, at 8 weeks and at 1 year with DIGS, FISC, EPDS and HAD, Stressful life events (Paykel). Blood are collected for all subjects for DNA extraction.
At week 8 and 1 year after pregnancy we search PPD with EDPS and DSM-IV criteria of depression".
- Conditions
- Postpartum Depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postpartum depression | caucasian mothers with postpartum depression | |
| control | caucasian mothers without depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression)
Postnatal depression detected by a possible depression (EPDS score > 8) and then confirmed (if EPDS score > 8) by DIGS DSM-IV depression criteria.
Measured: 8 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start2 Nov 2011
- Primary completion4 Sep 2016
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Dubertret, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648816
- Sponsor's protocol ID
- AOM 10056
- Other IDs
- 2010-A01315-35
- Acronym
- IGEDEPP
- Status last verified
- Sep 2023
- First submitted
- 20 Jul 2012
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tebeka S, Le Strat Y, Etain B, Ray M, Mullaert J, Dubertret C; IGEDEPP Study Group. Childhood Trauma and Perinatal Depression: Data From the IGEDEPP Cohort. J Clin Psychiatry. 2021 Sep 7;82(5):20m13664. doi: 10.4088/JCP.20m13664.
PubMed 34496464
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
- ClinicalTrials.gov ID
- NCT01648816
- Acronym / sponsor ID
- IGEDEPP / AOM 10056
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,338 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Nov 2011 (actual)
- Primary completion
- 4 Sep 2016 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 24 Jul 2012 (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.
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.
Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction)".
Detailed description
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.
Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction).
We want first to analyze the allelic association between SNPs of 5-HT, HPA and neurodevelopment genes and PPD with a case control association study We then analyse the interaction between maternal stressors during pregnancy and SNPS of our candidate genes (CRHR1, 5-HTT, TPH, BDNF, HMCN1).
3000 Caucasian mothers are included after pregnancy in 8 maternities and are evaluated at the inclusion, at 8 weeks and at 1 year with DIGS, FISC, EPDS and HAD, Stressful life events (Paykel). Blood are collected for all subjects for DNA extraction.
At week 8 and 1 year after pregnancy we search PPD with EDPS and DSM-IV criteria of depression".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postpartum depression | – | –caucasian mothers with postpartum depression |
| control | – | –caucasian mothers without depression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- causasian mothers after pregnancy
Key inclusion criteria (1 listed)
- Caucasian mothers included after pregnancy (J0-J4)
Key exclusion criteria (1 listed)
- Age <18 years old, schizophrenia or mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression)
Time frame: 8 weeks after delivery
Postnatal depression detected by a possible depression (EPDS score > 8) and then confirmed (if EPDS score > 8) by DIGS DSM-IV depression criteria.
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 8 Sep 2023.
- Derived from this study: PubMed 34496464Tebeka S, Le Strat Y, Etain B, Ray M, Mullaert J, Dubertret C; IGEDEPP Study Group. Childhood Trauma and Perinatal Depression: Data From the IGEDEPP Cohort. J Clin Psychiatry. 2021 Sep 7;82(5):20m13664. doi: 10.4088/JCP.20m13664.
- Individual participant dataSharing planned: Undecided
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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.
Caroline Dubertret, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 1 inclusion and 1 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 8 Sep 2023. 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 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?
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?
Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression) (time frame: 8 weeks after delivery). 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 NCT01648816, which also lists 1 linked publication.
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 8 Sep 2023.