Preventing Postpartum Depression With Intranasal Oxytocin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Postpartum, Anxiety

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, bonding, child development