Trial Outcomes & Findings for Intranasal Oxytocin and Maternal Neglect (NCT NCT02737436)
NCT ID: NCT02737436
Last Updated: 2025-01-28
Results Overview
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.
COMPLETED
NA
132 participants
30 minutes after intranasal spray is administered
2025-01-28
Participant Flow
132 mothers signed a consent form and enrolled in the study. Of these, 74 had at least one scanning session (and were assigned to an Arm), and 58 completed both scanning sessions. 45 individuals were included in the final scanning analysis, each of whom had 2 completed scans and usable data.
Unit of analysis: Scan
Participant milestones
| Measure |
PLACEBO FIRST GROUP: Functional MRI (fMRI) Following Placebo, Then fMRI Following Oxytocin
Intranasal spray given 50 minutes prior to fMRI scanning. On the first scanning visit, the participant received placebo; on the second scanning visit the participant received oxytocin.
|
OXYTOCIN FIRST GROUP: fMRI Following Oxytocin, Then fMRI Following Placebo
Intranasal spray given 50 minutes prior to fMRI scanning. On the first scanning visit, the participant received oxytocin (24 IU); on the second scanning visit the participant received placebo.
|
|---|---|---|
|
First Intervention (Day of 1st Scan)
STARTED
|
30 30
|
44 44
|
|
First Intervention (Day of 1st Scan)
COMPLETED
|
30 30
|
44 44
|
|
First Intervention (Day of 1st Scan)
NOT COMPLETED
|
0 0
|
0 0
|
|
Washout Period
STARTED
|
30 30
|
44 44
|
|
Washout Period
COMPLETED
|
25 25
|
33 33
|
|
Washout Period
NOT COMPLETED
|
5 5
|
11 11
|
|
Second Intervention (Day of 2nd Scan)
STARTED
|
25 25
|
33 33
|
|
Second Intervention (Day of 2nd Scan)
COMPLETED
|
25 25
|
33 33
|
|
Second Intervention (Day of 2nd Scan)
NOT COMPLETED
|
0 0
|
0 0
|
|
Data Analysis
STARTED
|
25 50
|
33 66
|
|
Data Analysis
COMPLETED
|
20 40
|
25 50
|
|
Data Analysis
NOT COMPLETED
|
5 10
|
8 16
|
Reasons for withdrawal
| Measure |
PLACEBO FIRST GROUP: Functional MRI (fMRI) Following Placebo, Then fMRI Following Oxytocin
Intranasal spray given 50 minutes prior to fMRI scanning. On the first scanning visit, the participant received placebo; on the second scanning visit the participant received oxytocin.
|
OXYTOCIN FIRST GROUP: fMRI Following Oxytocin, Then fMRI Following Placebo
Intranasal spray given 50 minutes prior to fMRI scanning. On the first scanning visit, the participant received oxytocin (24 IU); on the second scanning visit the participant received placebo.
|
|---|---|---|
|
Washout Period
Lost to Follow-up
|
5
|
11
|
|
Data Analysis
Scanning data problems
|
5
|
8
|
Baseline Characteristics
Intranasal Oxytocin and Maternal Neglect
Baseline characteristics by cohort
| Measure |
All Study Participants
n=45 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.6 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after intranasal spray is administeredPopulation: Participants were included if they completed both scans AND had good quality data on both scans. As pre-specified in the study protocol and similar to most functional MRI studies, the contrasts between two stimuli are reported (e.g., own vs unknown baby faces).
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.
Outcome measures
| Measure |
Placebo
n=45 Participants
Intranasal placebo spray given 50 minutes prior to scanning
Placebo: Intranasal placebo spray given 50 minutes prior to 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.
|
Oxytocin
n=45 Participants
Intranasal oxytocin (24IU) given 50 minutes prior to scanning
Intranasal Oxytocin: Intranasal oxytocin (24IU) given 50 minutes prior to 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.
|
|---|---|---|
|
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
Region of Interest (ROI) analysis (O>U): Ventral striatum activation
|
11.28 BOLD signal
Interval -1.71 to 24.27
|
11.06 BOLD signal
Interval -3.64 to 25.76
|
|
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
ROI analysis (O>U): Caudate activation
|
9.01 BOLD signal
Interval -2.54 to 20.56
|
43.32 BOLD signal
Interval 28.29 to 58.35
|
|
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
ROI analysis (O>U): Putamen activation
|
20.60 BOLD signal
Interval 11.72 to 29.48
|
25.34 BOLD signal
Interval 13.27 to 37.41
|
|
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
ROI analysis (O>U): Amygdala activation
|
25.57 BOLD signal
Interval 15.77 to 35.37
|
29.14 BOLD signal
Interval 14.17 to 44.11
|
|
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
ROI analysis (O>U): Medial prefrontal cortex activation
|
-9.93 BOLD signal
Interval -19.98 to 0.12
|
9.58 BOLD signal
Interval 0.45 to 18.71
|
Adverse Events
Placebo
Oxytocin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place