Postpartum DepressionNCT02020148
Can Oxytocin Level Predict Postpartum Depression?
An observational study of Postpartum Depression, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Pregnant Women
Who may be able to join
- At least 18 years of age
- English-speaking
- Pregnant (third trimester at time of visit)
Who cannot join
- Current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable)
- Current antidepressant treatment
- Severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease)
- Signs of multiple gestation or of fetal malformation in current pregnancy
- Cigarette smoking beyond 10th week of gestation of current pregnancy
- Pre-pregnancy BMI > 32
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Can Prenatal Plasma Oxytocin Concentration Predict Likelihood of Postpartum Depression? An Opportunity for Early Intervention and Prevention in a Vulnerable Population
The goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood.
Read the detailed description
Postpartum depression (PPD) 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 (OT), a hormone involved in delivery and lactation, has received recent attention regarding its additional role in maternal emotions and care taking behaviors after birth. The primary goal is explore the relationship between plasma oxytocin and postpartum mood.
- Conditions
- Postpartum Depression
- Keywords
- pregnancy, oxytocin, postpartum depression, depression, pregnant women, mood, anxiety, hormones, women's health, mental health, baby blues, mood disorders
- Medical subject headings
- Depression, Postpartum, Depression, Anxiety Disorders, Psychological Well-Being, Mood Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Depressive Symptomatology, Self-Report (IDS-SR-30)
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.
Measured: 4-6 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Suena H Massey, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020148
- Sponsor's protocol ID
- 00082402
- Status last verified
- Oct 2023
- First submitted
- 12 Dec 2013
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Bell AF, Carter CS, Steer CD, Golding J, Davis JM, Steffen AD, Rubin LH, Lillard TS, Gregory SP, Harris JC, Connelly JJ. Interaction between oxytocin receptor DNA methylation and genotype is associated with risk of postpartum depression in women without depression in pregnancy. Front Genet. 2015 Jul 21;6:243. doi: 10.3389/fgene.2015.00243. eCollection 2015.
PubMed 26257770
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Prenatal Plasma Oxytocin Concentration Predict Likelihood of Postpartum Depression? An Opportunity for Early Intervention and Prevention in a Vulnerable Population
- ClinicalTrials.gov ID
- NCT02020148
- Acronym / sponsor ID
- 00082402
- Conditions
- Postpartum Depression
- Keywords
- pregnancy, oxytocin, postpartum depression, depression, pregnant women, mood, anxiety, hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Dec 2013 (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.
The goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood.
Detailed description
Postpartum depression (PPD) 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 (OT), a hormone involved in delivery and lactation, has received recent attention regarding its additional role in maternal emotions and care taking behaviors after birth. The primary goal is explore the relationship between plasma oxytocin and postpartum mood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Pregnant Women
Key inclusion criteria (3 listed)
- At least 18 years of age
- English-speaking
- Pregnant (third trimester at time of visit)
Key exclusion criteria (6 listed)
- Current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable)
- Current antidepressant treatment
- Severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease)
- Signs of multiple gestation or of fetal malformation in current pregnancy
- Cigarette smoking beyond 10th week of gestation of current pregnancy
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Results publication: PubMed 26257770Bell AF, Carter CS, Steer CD, Golding J, Davis JM, Steffen AD, Rubin LH, Lillard TS, Gregory SP, Harris JC, Connelly JJ. Interaction between oxytocin receptor DNA methylation and genotype is associated with risk of postpartum depression in women without depression in pregnancy. Front Genet. 2015 Jul 21;6:243. doi: 10.3389/fgene.2015.00243. eCollection 2015.
- Reference citationLink provided by the sponsor.
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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.
Suena H Massey, MD principal investigator
Northwestern University
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 Postpartum Depression, run by Northwestern University at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Oct 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inventory of Depressive Symptomatology, Self-Report (IDS-SR-30) (time frame: 4-6 weeks post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020148, which also lists 1 linked publication.
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 Oct 2023.