Boston, Massachusetts 02114


Purpose:

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


Study summary:

Postpartum depression (PPD) is a debilitating disorder which imposes a threat to mother and infant heath. An estimated 600,000 American women suffer from PPD annually, making it one of the most frequent complications of pregnancy. Available secondary preventing interventions are often ineffective, which call 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. Posttraumatic symptoms following childbirth may over lap with the depression and complicate maternal bonding. Conventional pharmacotherapy does not help with bonding impairment. This feasibility study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk. Recent evidence in postpartum mothers indicates that high peripartum oxytocin levels are associated with enhanced maternal behavior and low levels with depression.Therefore, the investigators will test the therapeutic effects of oxytocin (OXT). It is hypothesized that administration of intranasal oxytocin (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 posttraumatic symptoms at 5 days postpartum, and 3) facilitate optimal child development.


Criteria:

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.


NCT ID:

NCT02505984


Primary Contact:

Principal Investigator
Sharon Dekel, PhD
Massachusetts General Hosptial

Sharon Dekel, PhD
Phone: 617-726-1352
Email: sdekel@mgh.harvard.edu


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States

Sharon Dekel, PhD
Phone: 617-726-1352
Email: sdekel@mgh.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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