Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression (IGEDEPP)
| Tracking Information | |||||
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| First Received Date ICMJE | July 20, 2012 | ||||
| Last Updated Date | January 30, 2013 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Depressed subject at Week 8 and at 1 year (EPDS and DSM I-V criteria for depression [ Time Frame: 8 weeks-1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Depressed subject at Week 8 (EPDS and DSM I-V criteria for depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01648816 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression | ||||
| Official Title ICMJE | Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression | ||||
| 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)". |
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| 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 7 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". |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | causasian mothers after pregnancy |
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| Condition ICMJE | Postpartum Depression | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Estimated Completion Date | November 2014 | ||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01648816 | ||||
| Other Study ID Numbers ICMJE | AOM 10056, 2010-A01315-35 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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