- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373709
Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Cases: Perinatal depression
Cases will be defined as those with a depressive episode with onset during the antenatal or postnatal period.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Perinatal depression
Time Frame: Antenatal and postnatal period
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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).
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Antenatal and postnatal period
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ene Choo Tan, Ph.D., KK Research Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Pathologic Processes
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Pregnancy Complications
- Behavioral Symptoms
- Mood Disorders
- Puerperal Disorders
- Disease Susceptibility
- Depression
- Depressive Disorder
- Depression, Postpartum
- Genetic Predisposition to Disease
Other Study ID Numbers
- 2010/539/F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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