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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
Sponsor:
Collaborator:
National University Hospital, Singapore
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief 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.

Condition or disease
Postnatal Depression Genetic Predisposition

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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
Saliva samples for DNA extraction


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese women attending antenatal and postnatal clinics in KK Women's and Children's Hospital and National University Hospital, Singapore.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
National University Hospital, Singapore
Investigators
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Principal Investigator: Ene Choo Tan, Ph.D. KK Research Centre
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02373709    
Other Study ID Numbers: 2010/539/F
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: August 2016
Additional relevant MeSH terms:
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Depression, Postpartum
Disease Susceptibility
Genetic Predisposition to Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Puerperal Disorders
Pregnancy Complications