Trial Outcomes & Findings for The Modulatory Effect of Oxytocin on Interoception (NCT NCT03074409)
NCT ID: NCT03074409
Last Updated: 2019-10-18
Results Overview
heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (\|recorded heartbeats - counted heartbeats\|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task.
COMPLETED
NA
83 participants
45 minutes after oxytocin/placebo treatment
2019-10-18
Participant Flow
Participant milestones
| Measure |
Oxytocin
intranasal administration of oxytocin
oxytocin: self-administration of oxytocin (nasal spray)
|
Placebo
intranasal administration of the same ingredient except oxytocin
placebo: self-administration of placebo (nasal spray)
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oxytocin
n=41 Participants
intranasal administration of oxytocin
oxytocin: self-administration of oxytocin (nasal spray)
|
Placebo
n=42 Participants
intranasal administration of the same ingredient except oxytocin
placebo: self-administration of placebo (nasal spray)
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.2 years
STANDARD_DEVIATION 2.5 • n=41 Participants
|
21.5 years
STANDARD_DEVIATION 2.4 • n=42 Participants
|
21.35 years
STANDARD_DEVIATION 4.45 • n=83 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=41 Participants
|
42 Participants
n=42 Participants
|
83 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
41 Participants
n=41 Participants
|
42 Participants
n=42 Participants
|
83 Participants
n=83 Participants
|
PRIMARY outcome
Timeframe: 45 minutes after oxytocin/placebo treatmentPopulation: 83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).
heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (\|recorded heartbeats - counted heartbeats\|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task.
Outcome measures
| Measure |
Oxytocin
n=37 Participants
intranasal administration of oxytocin
oxytocin: self-administration of oxytocin (nasal spray)
|
Placebo
n=38 Participants
intranasal administration of the same ingredient except oxytocin
placebo: self-administration of placebo (nasal spray)
|
|---|---|---|
|
Heartbeat Detection (Interoception) Accuracy
|
0.637 ratio of correct heartbeat counting
Standard Error 0.035
|
0.735 ratio of correct heartbeat counting
Standard Error 0.034
|
PRIMARY outcome
Timeframe: 45 minutes after oxytocin/placebo treatmentPopulation: 83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).
interoceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process).
Outcome measures
| Measure |
Oxytocin
n=37 Participants
intranasal administration of oxytocin
oxytocin: self-administration of oxytocin (nasal spray)
|
Placebo
n=38 Participants
intranasal administration of the same ingredient except oxytocin
placebo: self-administration of placebo (nasal spray)
|
|---|---|---|
|
Interoceptive Network Activity
|
0.548 percentage of BOLD signal change
Standard Error 0.095
|
0.091 percentage of BOLD signal change
Standard Error 0.092
|
Adverse Events
Oxytocin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shuxia Yao
University of Electronic Science and Technology of China
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place