CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Intranasal Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03593473
NCT03593473Phase 2Completed

The Psychobiology of Resilience in Mother-child Pairs: Inhaled Oxytocin and HPA Axis Reactivity

University of North Carolina, Chapel Hill·interventional·Posted Jul 20, 2018·Updated Aug 8, 2025

In Brief

A Phase 2 clinical trial evaluating Intranasal Oxytocin and Placebo for Depression, Postpartum and 2 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 20, 2018
Enrollment StartFeb 7, 2019
Primary CompletionJul 25, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.0 years ago

Interventions

Intranasal Oxytocindrug

Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.

Placebodrug

Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.