Intranasal Oxytocin and Maternal Neglect

NCT02737436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-01-28

Study results available
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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.

Conditions

  • Maternal Behavior

Interventions

DRUG

Intranasal Oxytocin

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

DRUG

Placebo

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

PROCEDURE

Functional MRI scanning

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.

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER
  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Lane Strathearn, MBBS PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737436 on ClinicalTrials.gov