CompletedPhase 2

Inhaled Oxytocin and HPA Axis Reactivity

United States109 participantsStarted 2019-02-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Singleton pregnancy;
✕. Intention to breastfeed (due to the centrality of breastfeeding to the oxytocin assessment);
✕. Intention to remain within 40 miles of the University of North Carolina - Chapel Hill through infant's first birthday;
✕. Ability to communicate in English.
✕. 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.
✕. Active substance abuse at enrollment in the 3rd trimester of pregnancy (Tobacco, alcohol, illicit substances);
✕. Major congenital anomaly;
✕. Chronic medication/medical condition contraindicated for breastfeeding;

What they're measuring

Mean Cortisol (CRT) During Trier Social Stress Test (TSST)

Timeframe: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes

Trial details

NCT IDNCT03593473

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-25

Results submitted2024-04-29

View on ClinicalTrials.gov More Depression, Postpartum trials