Can Oxytocin Level Predict Postpartum Depression?

• ClinicalTrials.gov Identifier: NCT02020148
• Recruitment Status: Unknown
• First Posted: December 24, 2013
• Last Update Posted: July 30, 2015
• Sponsor: Northwestern University
• Collaborator: Northwestern Memorial Hospital
• Information provided by (Responsible Party): Suena H Massey, MD, Northwestern University

Study Description

Brief Summary:

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 or disease
Postpartum Depression

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• 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
• Study Start Date: December 2013
• Actual Primary Completion Date: June 2015
• Estimated Study Completion Date: December 2015

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Inventory of Depressive Symptomatology, Self-Report (IDS-SR-30) [ Time Frame: 4-6 weeks post delivery ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Northwestern Memorial Hospital

Investigators

• Principal Investigator: Suena H Massey, MD; Northwestern University

More Information

Publications:

Skrundz M, Bolten M, Nast I, Hellhammer DH, Meinlschmidt G. Plasma oxytocin concentration during pregnancy is associated with development of postpartum depression. Neuropsychopharmacology. 2011 Aug;36(9):1886-93. doi: 10.1038/npp.2011.74. Epub 2011 May 11.

• Responsible Party: Suena H Massey, MD, Assistant Professor of Psychiatry and Behavioral Sciences, Northwestern University
• ClinicalTrials.gov Identifier: NCT02020148
• Other Study ID Numbers: 00082402
• First Posted: December 24, 2013
• Last Update Posted: July 30, 2015
• Last Verified: July 2015

Keywords provided by Suena H Massey, MD, Northwestern University:

pregnancy; oxytocin; postpartum depression; depression; pregnant women; mood; anxiety; hormones; women's health; mental health; baby blues; mood disorders

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications