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NCT Number: NCT02505984

Preventing Postpartum Depression With Intranasal Oxytocin

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.

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Key information

Conditions

Depression, Postpartum Anxiety Anxiety Disorders Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Failure to participate in regular prenatal check-ups
  • Current diagnosis Diagnostic and Statistical Manual of Mental Disorders (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

Treatment and study plan

Oxytocin

Drug

Study participants will be randomized to a placebo or drug group.

Other names: Syntocinon

Placebo

Drug

Study participants will be randomized to a placebo or drug group.

Other names: Salt solution

Primary outcomes

  1. Treatment Effect on Mother-infant Bonding

    Time frame: 5 days and 2 months postpartum (on average)

    Day 5 postpartum:

    Self-report assessment of maternal bonding (Maternal Attachment Inventory, higher scores means better outcome, range 26 -104)

    2 months postpartum: Quantitative observational assessment of mother-infant bonding (Coding Interactive Behavior; mean score represents mean score of the study sample. Negative bonding includes age-appropriate items on maternal intrusiveness, infant withdrawal, and dyad negative sub-scales, higher scores indicate higher levels of negative bonding behavior (deviation above the mean represent worse outcome); positive bonding includes maternal sensitivity, maternal limit setting, infant involvement, and dyad reciprocity sub-scales, higher scores indicate higher levels of bonding behavior, deviation above the mean represent better outcome); and repeat of self-report (MAI)

Secondary outcomes

  1. Treatment Effect on Maternal Depression Symptoms

    Time frame: Baseline and 5 days postpartum

    Self-reported assessment of severity of maternal depression symptoms (Edinburgh Postnatal Depression Scale, higher scores mean worse outcome, range 0 - 30).

  2. Treatment Effect on Maternal Anxiety Symptoms

    Time frame: Baseline and 5 days postpartum

    Self-reported severity of maternal anxiety symptoms (Brief Symptom Inventory, Anxiety sub-scale, higher scores means worse outcome, range 0 - 24).

  3. Child Development

    Time frame: 2 months postpartum (on average)

    Quantitative observational assessment of infant communication, cognitive, and motor development (Bayley Scales of Infant Development, screening, higher scores better outcome, ranges for each subscale are reported for infants 1-6 months old (items are scored either 0 or 1) - communication scale range 0-4, cognitive scale range 0-7, motor scale range 0-12; note: Bayley Scales can be performed for up to 42 months old infants; developmentally advanced infants may achieve scores above the reported range scale above)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: IN-OXT

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2015
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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