Can Oxytocin Level Predict Postpartum Depression?

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Northwestern University
Sponsor:
Collaborator:
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Suena H Massey, MD, Northwestern University
ClinicalTrials.gov Identifier:
NCT02020148
First received: December 12, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood. Based on previous research, the investigators hypothesize that lower plasma oxytocin concentration during pregnancy will predict a greater likelihood of postpartum depression. Second, it is expected that oxytocin concentration in the third trimester will show an inverse relationship with the severity of depressive symptoms at 4 - 6 weeks postpartum.

Potential participants in the study will be screened for eligibility during their third trimester of pregnancy, using a combination of questionnaires. Those who are eligible for participation will have one blood sample drawn at this time, and then be asked to complete a follow up questionnaire at 4-6 weeks postpartum to assess for depressive mood symptoms. This follow up questionnaire can be completed either in person or on the telephone. Anyone who is interested in receiving help for their mood at any point in the study will receive referrals.


Condition
Postpartum Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Prenatal Plasma Oxytocin Concentration Predict Likelihood of Postpartum Depression? An Opportunity for Early Intervention and Prevention in a Vulnerable Population

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Inventory of Depressive Symptomatology, Self-Report (IDS-SR-30) [ Time Frame: 4-6 weeks post delivery ] [ Designated as safety issue: No ]
    The IDS-SR-30 is a validated, widely used tool to evaluate depressive symptoms and clinical depression. Participants will complete this questionnaire in person or through telephone interview.


Biospecimen Retention:   Samples Without DNA

A 3 milliliter (about half a teaspoon) blood sample will be obtained to measure oxytocin level.


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Postpartum depression affects some one in five new mothers, and adversely influences maternal adaptation to motherhood. While it is known that women with a prior history of depression, or depression during pregnancy, are at elevated risk for postpartum depression, many women with no prior history of depression or other risk factors go on to develop depression in the postpartum period. Considering the grave consequences of postpartum depression on maternal infant bonding and childhood psychological development, it is critical to develop reliable methods to identify which women, who are not depressed during pregnancy, will become depressed after delivery.

The biological pathways leading to depression at any time in life, including around pregnancy, are still poorly characterized. Oxytocin, a hormone involved in delivery and lactation, has received recent attention regarding its additional role in maternal emotions and care taking behaviors after birth. Specifically, lower plasma oxytocin concentration in the third trimester of pregnancy has been linked to an increased risk of depression at two weeks postpartum (Skrundz et al., 2001).

The primary goal of this study is to replicate previous findings and clarify whether oxytocin is predictive of clinically significant depression at 4 - 6 weeks postpartum, using a more comprehensive diagnostic measure for depression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Pregnant Women

Criteria

Inclusion Criteria:

  1. At least 18 years of age
  2. English-speaking
  3. Pregnant (third trimester at time of visit)

Exclusion Criteria:

  1. Current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable)
  2. Current antidepressant treatment
  3. Severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease)
  4. Signs of multiple gestation or of fetal malformation in current pregnancy
  5. Cigarette smoking beyond 10th week of gestation of current pregnancy
  6. Pre-pregnancy BMI > 32
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020148

Contacts
Contact: Stephanie A Schuette, BA 312-695-6010 nwu-sas375@northwestern.edu
Contact: Suena H Massey, MD (312) 695-6479 suena.massey@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Stephanie A Schuette, BA    312-695-6010    nwu-sas375@northwestern.edu   
Principal Investigator: Suena Massey, MD         
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
Investigators
Principal Investigator: Suena H Massey, MD Northwestern University
  More Information

Additional Information:
Publications:
Responsible Party: Suena H Massey, MD, Assistant Professor of Psychiatry and Behavioral Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT02020148     History of Changes
Other Study ID Numbers: 00082402
Study First Received: December 12, 2013
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
women's health
pregnancy
oxytocin
postpartum depression
depression
pregnant women
mood
anxiety
hormones
mental health
baby blues
mood disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014