IN-OXT: Preventing Postpartum Depression With Intranasal Oxytocin

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02505984

Collaborator

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

110

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression, Postpartum Anxiety	Drug: Oxytocin Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxytocin Sub-group of participants receiving oxytocin nasal spray (Syntocinon)	Drug: Oxytocin Study participants will be randomized to a placebo or drug group. Other Names: Syntocinon
Placebo Comparator: Placebo Sub-group of participants receiving placebo nasal spray	Drug: Placebo Study participants will be randomized to a placebo or drug group. Other Names: Salt solution

Arm

Intervention/Treatment

Active Comparator: Oxytocin

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

Drug: Oxytocin

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

Other Names:

Syntocinon

Placebo Comparator: Placebo

Sub-group of participants receiving placebo nasal spray

Drug: Placebo

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

Other Names:

Salt solution

Outcome Measures

Primary Outcome Measures

Treatment effect on mother-infant bonding [Day 5 postpartum and 2 months postpartum]
Day 5 postpartum: Self-report assessment of maternal bonding 2 months postpartum: Quantitative observational assessment of mother-infant bonding and repeat of self-reports

Secondary Outcome Measures

Change in depression symptoms [Baseline and day 5 postpartum]
Self-reported severity of depression symptoms
Change in anxiety symptoms [Baseline and day 5 postpartum]
Self-reported severity of anxiety symptoms
Child development [2 months postpartum]
Quantitative observational assessment of infant socio-emotional, cognitive, and motor development

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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