CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
Intranasal Oxytocin +2 moredrug
Likely dose
Intranasal Oxytocin 24IUfrom 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/NCT02737436
NCT02737436N/ACompleted
CompareCT.gov

Intranasal Oxytocin: A Neuropharmacological Intervention for Maternal Neglect?

Baylor College of Medicine·interventional·Posted Apr 14, 2016·Updated Jan 28, 2025

In Brief

A clinical study evaluating Intranasal Oxytocin, Placebo, and 1 other intervention for Maternal Behavior. Completed, enrolled 132 participants across 2 sites.

Detailed Summary

The investigators plan to conduct functional MRI scanning with a group of mothers who are blindly and randomly assigned either intranasal oxytocin or a placebo. The purpose of this investigation is to explore how oxytocin may modify early maternal brain and behavioral responses to infant cues. This study will examine, for the first time, a potential pharmacological intervention for maternal neglect which targets core neurobiological deficits. This may eventually be used to supplement and augment other psychosocial and behavioral interventions. In addition, the investigators will examine sex differences in parental brain and behavioral responses to oxytocin by also recruiting fathers to participate in a similar protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMaternal Behavior
CountriesUnited States
CollaboratorsUniversity of Iowa

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2016
Enrollment StartMay 1, 2010
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 10.2 years ago

Interventions

Intranasal Oxytocindrug

Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning

Placebodrug

Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning

Functional MRI scanningprocedure

All study participants underwent two functional MRI scanning visits. On one occasion this was after receiving an intranasal dose of oxytocin; on the other occasions, after receiving intranasal placebo dose.