Inhaled Oxytocin and HPA Axis Reactivity

• Status: Enrolling by invitation
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Mothers who were enrolled in the Mood, Mother and Infant study will be eligible to participate in the 6-year follow-up maternal visit. At the time of this visit, mothers will be randomized to a single 24 IU dose of nasal oxytocin or placebo. Following administration of the study drug, women will participate in the Trier Social Stress Test (TSST), and blood samples will be collected to quantify HPA axis reactivity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Oxytocin

Criteria

This study will follow-up the existing Mood, Mother and Infant (MMI) prospective longitudinal cohort (R01HD073220), comprised of 222 mother-infant dyads who were recruited between May 2013 and April 2017 and completed the 12-month MMI visit. In the MMI study, 222 mothers ages 18-45 and their infants were enrolled. Participants were recruited from community clinics in the third trimester of pregnancy and continued to participate in the study through 12 months postpartum. At the 12-month visit, mothers were invited to continue to be followed via online surveys at 6-month intervals; more than 80% of women who have completed the MMI study to date have continued to participate. Enrolled participants in the MMI study met the following inclusion and exclusion criteria:

Inclusion Criteria:

1. Singleton pregnancy;

2. Intention to breastfeed (due to the centrality of breastfeeding to the oxytocin assessment);

3. Intention to remain within 40 miles of the University of North Carolina - Chapel Hill through infant's first birthday;

4. Ability to communicate in English.

Exclusion Criteria:

1. Maternal diagnosis of Axis I disorders other than unipolar depression or anxiety disorders. Women with a history of bipolar disorder were excluded, given their increased risk of postpartum psychosis.

2. Active substance abuse at enrollment in the 3rd trimester of pregnancy (Tobacco, alcohol, illicits);

3. Major congenital anomaly;

4. Chronic medication/medical condition contraindicated for breastfeeding;

5. Current use of tricyclic antidepressants, which alter cortisol and heart rate variability.

At enrollment, all participants underwent a Structured Clinical Interview Non-Patient version (SCID-NP).

Inclusion Criteria for Inhaled Oxytocin and HPA Axis Reactivity, a substudy of the Psychobiology of Resilience in Mother-Child Pairs follow-up study: 1) Participated in the MMI study 2) Both mother and child willing and able to participate in the 6-year follow-up visits 3) Not pregnant, verified by urine pregnancy test on day of study visit.