Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression

Genetic Predisposition Clinical Trial

Official title:

Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02373709
• Other study ID #: 2010/539/F
• Status: Active, not recruiting
• Start date: October 2010
• Est. completion date: December 2025

Study information

• Verified date: October 2021
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To elucidate the disease pathway of perinatal depression by identifying genetic variants which could play a role in predisposing to the condition and/or lead to better understanding of the pathogenesis of the condition. This is achieved by investigating for associations between oestrogen receptor genetic variants and perinatal depression.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• Anthropometric profile: age 21-35 years; Chinese race; Chinese ancestry for all 4 grandparents

• Natural conception (not artificially assisted)

• Cases: depressive episode during antenatal period or < 6 months postnatal at time of recruitment; patients with past diagnosis of depression must have been well for 3 months before pregnancy

• Controls: well during antenatal period or > 6 months postnatal at time of recruitment; no family history of depression or affective disorders

Exclusion Criteria:

• Other psychiatric disorders (non-mood disorders) namely schizophrenia and substance dependence

• Previously diagnosed neurological disorders

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Postnatal Depression

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal depression	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).	Antenatal and postnatal period