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

Postpartum Depression Clinical Trial

— IGEDEPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648816
• Other study ID #: AOM 10056
• Secondary ID: 2010-A01315-35
• Status: Completed
• Start date: November 2, 2011
• Est. completion date: July 20, 2017

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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)".

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3338
• Est. completion date: July 20, 2017
• Est. primary completion date: September 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria:

• Age <18 years old, schizophrenia or mental retardation

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Locations

Country	Name	City	State
France	Louis Mourier Hospital	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks after delivery