Trial Outcomes & Findings for Oxytocin's Effect on Socioemotional Aging (NCT NCT01823146)
NCT ID: NCT01823146
Last Updated: 2016-08-25
Results Overview
Average amount of monetary units invested in the context of the Trust/Lottery Game. The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately.
COMPLETED
NA
106 participants
45 minutes after drug/placebo administration
2016-08-25
Participant Flow
Participants were recruited between 08/2013 and 09/2014. Recruitment phone calls were conducted at the Social-Cognitive and Affective Development Lab at University of Florida.
Participant milestones
| Measure |
Oxytocin Spray
single dose of 24 IU oxytocin, self-administered intranasally (IN)
|
Placebo Spray
single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
51
|
|
Overall Study
COMPLETED
|
53
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Oxytocin Spray
single dose of 24 IU oxytocin, self-administered intranasally (IN)
|
Placebo Spray
single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Oxytocin's Effect on Socioemotional Aging
Baseline characteristics by cohort
| Measure |
Oxytocin Spray
n=55 Participants
single dose of 24 IU oxytocin, self-administered intranasally (IN)
|
Placebo Spray
n=51 Participants
single dose of 24 IU saline, self-administered intranasally (IN)
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
51 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 45 minutes after drug/placebo administrationPopulation: All study participants who had undergone the screening as well as the full visit (n = 102).
Average amount of monetary units invested in the context of the Trust/Lottery Game. The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately.
Outcome measures
| Measure |
Oxytocin Spray
n=53 Participants
single dose of 24 IU oxytocin, self-administered intranasally (IN)
|
Placebo Spray
n=49 Participants
single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
|
|---|---|---|
|
Extent of Trust Behavior
non-social trials
|
39.03 monetary units
Standard Error 2.55
|
44.42 monetary units
Standard Error 2.54
|
|
Extent of Trust Behavior
social trials
|
45.11 monetary units
Standard Error 1.86
|
46.06 monetary units
Standard Error 2.47
|
SECONDARY outcome
Timeframe: 2.5 hours after drug/placebo administrationPopulation: All study participants who had undergone the screening as well as the full visit (n = 102).
Mean self-reported level of meta-mood for the two subscales attention to feelings and clarity of feelings. Response scale ranged from 1 to 5, with higher scores indicating more attention to feelings and greater clarity of feelings, respectively. The mean score for the subscales were calculated.
Outcome measures
| Measure |
Oxytocin Spray
n=53 Participants
single dose of 24 IU oxytocin, self-administered intranasally (IN)
|
Placebo Spray
n=49 Participants
single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
|
|---|---|---|
|
Meta-Mood
n = 24 older men (63 to 85 years)
|
3.38 units on a scale
Standard Error .18
|
2.977 units on a scale
Standard Error .19
|
|
Meta-Mood
n = 30 older women (63 to 85 years)
|
3.23 units on a scale
Standard Error .18
|
3.63 units on a scale
Standard Error .17
|
|
Meta-Mood
n = 25 young men (18 to 30 years)
|
3.54 units on a scale
Standard Error .17
|
3.58 units on a scale
Standard Error .20
|
|
Meta-Mood
n = 23 young women (18 to 30 years)
|
4.04 units on a scale
Standard Error .19
|
3.68 units on a scale
Standard Error .21
|
SECONDARY outcome
Timeframe: 1.5 hours after oxytocin/placebo administrationPopulation: All study participants who had undergone the screening as well as the full visit and had reliable resting fMRI scan data (e.g., low extent of head motion) (n = 79).
The functional connectivity (strength measure in units on a scale) between amygdala and medial prefrontal cortex was measured via a resting functional magnetic resonance imaging scan (participants looked at a fixation cross while images of their brain at rest were taken). Functional connectivity is the connectivity between brain regions (i.e., amygdala and medial prefrontal cortex) that share functional properties. It is defined as the temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. A mean of this correlation (connectivity strength) was computed and transformed into z-scores (r to z transformation). The z-scores ranged from -2 to +2 with higher scores representing a greater resting-state functional connectivity.
Outcome measures
| Measure |
Oxytocin Spray
n=40 Participants
single dose of 24 IU oxytocin, self-administered intranasally (IN)
|
Placebo Spray
n=39 Participants
single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
|
|---|---|---|
|
Functional Connectivity (Resting fMRI)
|
0.58 z-scores
Interval 0.49 to 0.66
|
0.48 z-scores
Interval 0.39 to 0.57
|
Adverse Events
Oxytocin Spray
Placebo Spray
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