N/A
N=74
Intranasal Oxytocin and Maternal Neglect
Maternal Behavior
Bottom Line
View on ClinicalTrials.gov: NCT02737436 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers — 11.28; 11.06; 9.01; 43.32 BOLD signal
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intranasal Oxytocin (Drug); Placebo (Drug); Functional MRI scanning (Procedure)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers |
11.28; 11.06; 9.01; 43.32; 20.60; 25.34 | — |
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.
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02737436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.