Postnatal DepressionNCT02373709
Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression
An observational study of Postnatal Depression and Genetic Predisposition, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Postnatal Depression, Genetic Predisposition
- How many people
- 750 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2010to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Chinese women attending antenatal and postnatal clinics in KK Women's and Children's Hospital and National University Hospital, Singapore.
Who may be able to join
- 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
Who cannot join
- Other psychiatric disorders (non-mood disorders) namely schizophrenia and substance dependence
- Previously diagnosed neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postnatal Depression, Genetic Predisposition
- Medical subject headings
- Depression, Postpartum, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Antenatal and postnatal period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startOct 2010
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Ene Choo Tan, Ph.D., Principal investigator, KK Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373709
- Sponsor's protocol ID
- 2010/539/F
- Status last verified
- Nov 2024
- First submitted
- 22 Feb 2015
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression
- ClinicalTrials.gov ID
- NCT02373709
- Acronym / sponsor ID
- 2010/539/F
- Conditions
- Postnatal Depression, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National University Hospital, Singapore
- Study start
- Oct 2010
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chinese women attending antenatal and postnatal clinics in KK Women's and Children's Hospital and National University Hospital, Singapore.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Other psychiatric disorders (non-mood disorders) namely schizophrenia and substance dependence
- Previously diagnosed neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ene Choo Tan, Ph.D. principal investigator
KK Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Depression and Genetic Predisposition, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal depression (time frame: Antenatal and postnatal period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.