Preventing Postpartum Depression With Intranasal Oxytocin (IN-OXT)

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Depression, Postpartum; Anxiety

Treatments: Drug: Oxytocin; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02505984

2015P001100

224421 (Other Grant/Funding Number)

225686 (Other Grant/Funding Number)

1R21HD090396-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Oxytocin

Active Comparator group

Description:

Sub-group of participants receiving oxytocin nasal spray (Syntocinon)

Treatment:

Drug: Oxytocin

Placebo

Placebo Comparator group

Description:

Sub-group of participants receiving placebo nasal spray

Treatment:

Drug: Placebo