Clinical trial NCT01648816: Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
Official title: Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Depression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 3338
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: causasian mothers after pregnancy

Brief 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)".

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".

Eligibility criteria: Inclusion Criteria:

* Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria:

* Age \<18 years old, schizophrenia or mental retardation

Primary outcomes:
measure: Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression)
timeFrame: 8 weeks after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Caroline Dubertret, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.