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Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression (IGEDEPP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648816
First Posted: July 24, 2012
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
July 20, 2012
July 24, 2012
June 15, 2017
November 2, 2011
September 4, 2016   (Final data collection date for primary outcome measure)
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.
Depressed subject at Week 8 (EPDS and DSM I-V criteria for depression [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01648816 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression

"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)".

"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".

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood sample
Non-Probability Sample
causasian mothers after pregnancy
Postpartum Depression
Not Provided
  • postpartum depression
    caucasian mothers with postpartum depression
  • control
    caucasian mothers without depression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
September 2017
September 4, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria:

  • Age <18 years old, schizophrenia or mental retardation
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01648816
AOM 10056
2010-A01315-35 ( Other Grant/Funding Number: ID-RCB )
Yes
Not Provided
Plan to Share IPD: Undecided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Director: Caroline Dubertret, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2017