Preventing Postpartum Depression With Intranasal Oxytocin

Phase 2

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin	Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
Placebo	Placebo	Sub-group of participants receiving placebo nasal spray

Primary Outcome Measures

Name	Time	Method
Treatment Effect on Mother-infant Bonding	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 Outcome Measures

Name	Time	Method
Treatment Effect on Maternal Depression Symptoms	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).
Treatment Effect on Maternal Anxiety Symptoms	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).
Child Development	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)