Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression
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|ClinicalTrials.gov Identifier: NCT02373709|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2015
Last Update Posted : March 13, 2019
|Condition or disease|
|Postnatal Depression Genetic Predisposition|
Perinatal (antenatal and postnatal) depression is a common complication of childbearing, affecting 10 to 20% of mothers. In general, women are exposed to fluctuations in estrogen level during childbearing years, especially during pregnancy and following childbirth. For a subgroup of women with genetic predisposition rendering them more sensitive to such changes, pregnancy or childbirth can act as a trigger for the onset of perinatal depression.
A case control study will be conducted to evaluate the association of variants in estrogen receptor and related genes with the disorder in our population. Women attending antenatal and postnatal clinics will be screened with the Edinburgh Postnatal Depression Scale and cases will be identified. DNA from controls who are well throughout the antenatal and postpartum period and cases meeting DSM IV criteria for depressive disorder will be genotyped for various genetic variants. The distribution of single nucleotide polymorphisms and haplotypes and non-genetic risk factors will be compared between cases and controls and within the case group. The risk factors for postnatal depression in relation to peripartum factors such as demographic, obstetric, anaesthetic and pain outcomes will be investigated.
As perinatal depression is known to contribute to inadequate self-care and poor compliance with prenatal care, early diagnosis and treatment interventions are critical for the health and well-being of both mother and infant. In the short term, identified genetic markers that increase vulnerability to puerperal triggering of depression can be an additional screening tool to identify at-risk expectant mothers for early management during a very critical period for mother, infant, and family. In the long run, it may lead to identification of new pathways or treatment targets for this common but under-studied disorder.
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Cases: Perinatal depression
Cases will be defined as those with a depressive episode with onset during the antenatal or postnatal period.
Controls: No perinatal depression
Controls will be defined as those who score < 7 on Edinburgh Postnatal Depression Scale and/or no episode of clinical depression from pregnancy until 6 months postnatal.
- Perinatal depression [ Time Frame: Antenatal and postnatal period ]Defined as meeting Diagnostic and Statistical Manual for Psychiatric Disorders, Fourth Edition (DSM-IV) criteria for major depression through an interview by a clinician using Structured Clinical Interview for Diagnosis (SCID).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373709
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Ene Choo Tan, Ph.D.||KK Research Centre|