Intranasal Oxytocin and Maternal Neglect

Completed · Not applicable · Has a placebo group

Conditions studied: Maternal Behavior

In brief

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.

Key facts

Study ID

NCT02737436

Run by

Baylor College of Medicine

People needed

132

Starts

2010-05-01

Expected to finish

2019-03-01

Last updated by the study team

2025-01-28

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In order to fulfill enrollment criteria, the women must:
• be first-time parent(s)
• who have just delivered a term infant >37 weeks gestation, without medical complications.
• She should be:
• aged between 20 and 45 years;
• and be English speaking from childhood (required for accurate coding of attachment interview).
• For male partners:
• First-time fathers;
• have female partners who just delivered a term infant >37 weeks gestation, without medical complications;
• aged between 20 and 45 years;
• English speaking from childhood

You may not qualify if…

• Those who meet the following, will be excluded:
• History of head injury resulting in loss of consciousness for >10 minutes;
• neurological disease, including stroke, brain tumor, meningitis or encephalitis;
• any contraindications to MRI scanning, e.g. pacemakers, aneurysm clips, neurostimulators, fixed hearing devices, metal in eyes, or other implants;
• previous inability to tolerate MRI scanning procedure, or claustrophobia; and
• a past history of drug addiction or serious psychopathology, other than anxiety or depression.

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Children's Nutrition Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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