Intranasal Oxytocin and Maternal Neglect

Short name OT-MOM

NCTNCT02737436Other idH-26732

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 132 participants (actual)
Sponsor: Baylor College of Medicine · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: May 2010
Primary completion: Mar 2019
Completion: Mar 2019
First posted: 14 Apr 2016 (estimated)
Last update posted: 28 Jan 2025
Conditions: Maternal Behavior

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020122014201620182020

N/A
OT-MOM
NCT02737436
May 2010 to Mar 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Intranasal OxytocinDrug
PlaceboDrug
Functional MRI scanningProcedure

Arms2

Experimental
Oxytocin
Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
Experimental
Placebo
Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning

Primary outcomes1

Outcomes the sponsor listed as primary.

Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
Time frame · 30 minutes after intranasal spray is administered
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 30 minutes after intranasal spray is administered

Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers

Group	Value (BOLD signal)
Placebo	11.28
Oxytocin	11.06

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboIntranasal placebo spray given 50 minutes prior to behavior assessment or scanning Placebo: Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning 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.	0 / 63	0 / 63	0 / 63
OxytocinIntranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning Intranasal Oxytocin: Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning 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.	0 / 69	0 / 69	0 / 69

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: In order to fulfill enrollment criteria, the women must: 1. be first-time parent(s) 2. who have just delivered a term infant \>37 weeks gestation, without medical complications. She should be: 3. aged between 20 and 45 years; 4. and be English speaking from childhood (required for accurate coding of attachment interview). For male partners: 1. First-time fathers; 2. have female partners who just delivered a term infant \>37 weeks gestation, without medical complications; 3. aged between 20 and 45 years; 4. English speaking from childhood Exclusion Criteria: Those who meet the following, will be excluded: 1. History of head injury resulting in loss of consciousness for \>10 minutes; 2. neurological disease, including stroke, brain tumor, meningitis or encephalitis; 3. any contraindications to MRI scanning, e.g. pacemakers, aneurysm clips, neurostimulators, fixed hearing devices, metal in eyes, or other implants; 4. previous inability to tolerate MRI scanning procedure, or claustrophobia; and 5. a past history of drug addiction or serious psychopathology, other than anxiety or depression.

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