Inhaled Oxytocin and HPA Axis Reactivity

Phase 2 Completed 109 enrolled University of North Carolina, Chapel Hill Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupQuadruple-blindBasic science

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.

Timeline

Start: 2019-02-07
Primary completion: 2023-07-25
Completion: 2023-07-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Intranasal Oxytocin vs Placebo; p = 0.37; t-test, 2 sided NCT03593473 ↗

Publications

Mills-Koonce WR, Grewen K, O'Shea NG, Pearson B, Strange CG, Meltzer-Brody SE, Guintivano JD, Stuebe AM. The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 26;12:e51132. doi: 10.2196/51132.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxytocin	Peptide	24 iu	Intranasal