NCT02373709

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Oct 2010Dec 2028

Study Start

First participant enrolled

October 1, 2010

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

18.2 years

First QC Date

February 22, 2015

Last Update Submit

November 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Chinese women attending antenatal and postnatal clinics in KK Women's and Children's Hospital and National University Hospital, Singapore.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples for DNA extraction

MeSH Terms

Conditions

Depression, PostpartumGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ene Choo Tan, Ph.D.

    KK Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2015

First Posted

February 27, 2015

Study Start

October 1, 2010

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations