Intranasal Oxytocin and Maternal Neglect
OT-MOM
Intranasal Oxytocin: A Neuropharmacological Intervention for Maternal Neglect?
1 other identifier
interventional
132
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
January 28, 2025
CompletedJanuary 28, 2025
January 1, 2025
8.8 years
March 16, 2016
July 12, 2023
January 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
We will compare the BOLD signal of regions in the brain (including the ventral striatum, caudate, putamen, amygdala, and the medial prefrontal cortex) in mothers who receive intranasal oxytocin, compared to placebo. In every analysis, we measure the difference in brain response (BOLD signal) between viewing the mother's own infant (O) more than unknown infant (U) faces (O\>U), during fMRI scanning.
30 minutes after intranasal spray is administered
Study Arms (2)
Oxytocin
EXPERIMENTALIntranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
Placebo
EXPERIMENTALIntranasal placebo spray given 50 minutes prior to behavior assessment or scanning
Interventions
Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
Intranasal placebo spray given 50 minutes prior to behavior assessment or 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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- University of Iowacollaborator
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Children's Nutrition Research Center
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Lane Strathearn
- Organization
- University of Iowa
Study Officials
- PRINCIPAL INVESTIGATOR
Lane Strathearn, MBBS PhD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 16, 2016
First Posted
April 14, 2016
Study Start
May 1, 2010
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
January 28, 2025
Results First Posted
January 28, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share