Preventing Postpartum Depression With Intranasal Oxytocin (IN-OXT)

May 4, 2023 updated by: Sharon Dekel, PhD, Massachusetts General Hospital

Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD

The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postpartum depression (PPD) is a debilitating disorder which imposes a threat to mother and infant health. An estimated 600,000 American women suffer from PPD annually, making it one of the most frequent complications of pregnancy. Available secondary preventive interventions are often ineffective, which calls for identifying novel means for prevention. Impaired mother-infant bonding is a hallmark of PPD. Depressed mothers may have difficulties developing maternal feelings and providing sensitive care. In turn, impaired bonding may worsen mother's depression. Conventional pharmacotherapy does not help with bonding impairment.

This study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk. Evidence in postpartum mothers indicates that high peripartum OXT levels are associated with enhanced maternal behavior and low levels with depression. Data also indicates that in depressed mothers, OXT levels may decrease during the first days following childbirth rather than increase as is the norm. Therefore, the investigators will test the therapeutic effects of OXT in women at risk for PPD. It is hypothesized that administration of IN-OXT (total daily dose 48 IU) over the course of four days from as early as day one postpartum in comparison to placebo will 1) enhance mother-infant bonding, 2) reduce depressive and anxiety symptoms at 5 days postpartum, and 3) facilitate child development.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Third-trimester pregnant women being followed at the MGH Obstetrics Program
  • At risk of postpartum depression (PPD)

Exclusion Criteria:

  • Failure to participate in regular prenatal check-ups
  • Current diagnosis DSM-5 mental disorder pertaining to psychosis or substance abuse
  • Suicidality
  • Obstetric complication (e.g., preeclampsia, excessive hemorrhaging)
  • Use of potentially confounding or interacting medications
  • Complicating pediatric medical condition in the newborn

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin
Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
Drug: Oxytocin
Study participants will be randomized to a placebo or drug group.
Other Names:
  • Syntocinon
Placebo Comparator: Placebo
Sub-group of participants receiving placebo nasal spray
Drug: Placebo
Study participants will be randomized to a placebo or drug group.
Other Names:
  • Salt solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment effect on mother-infant bonding
Time Frame: Day 5 postpartum and 2 months postpartum

Day 5 postpartum:

Self-report assessment of maternal bonding

2 months postpartum: Quantitative observational assessment of mother-infant bonding and repeat of self-reports
Day 5 postpartum and 2 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression symptoms
Time Frame: Baseline and day 5 postpartum
Self-reported severity of depression symptoms
Baseline and day 5 postpartum
Change in anxiety symptoms
Time Frame: Baseline and day 5 postpartum
Self-reported severity of anxiety symptoms
Baseline and day 5 postpartum
Child development
Time Frame: 2 months postpartum
Quantitative observational assessment of infant socio-emotional, cognitive, and motor development
2 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Sharon Dekel, PhD, Massachusetts General Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

July 19, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P001100
  • 224421 (Other Grant/Funding Number: Claflin Distinguished Scholar Award)
  • 225686 (Other Grant/Funding Number: Brain & Behavior Research Foundation)
  • 1R21HD090396-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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