Trial Outcomes & Findings for Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder (NCT NCT01856530)
NCT ID: NCT01856530
Last Updated: 2018-02-13
Results Overview
The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as "Player 2") played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1.
COMPLETED
PHASE1/PHASE2
60 participants
Day 1 (first day oxytocin or placebo was administered)
2018-02-13
Participant Flow
Although 60 participants were enrolled in the study, 6 participants were found to be ineligible due to meeting criteria for substance dependence (n=2), a primary diagnosis of posttraumatic stress disorder (n=1), and not meeting criteria for social anxiety disorder (n=3). Therefore, only 54 participants were assigned to groups.
Participant milestones
| Measure |
Oxytocin
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Oxytocin
n=27 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=27 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
Total
n=54 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
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (first day oxytocin or placebo was administered)Population: Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54.
The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as "Player 2") played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1.
Outcome measures
| Measure |
Oxytocin
n=26 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=26 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Social Cooperation
|
4.42 Ball tosses
Standard Deviation 6.706
|
4.69 Ball tosses
Standard Deviation 6.078
|
PRIMARY outcome
Timeframe: Day 1 (first day oxytocin or placebo was administered)The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement.
Outcome measures
| Measure |
Oxytocin
n=27 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=27 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Disengagement From Social Threat Cues
|
1.34 Milliseconds
Standard Deviation 36.79
|
-2.69 Milliseconds
Standard Deviation 52.39
|
SECONDARY outcome
Timeframe: Day 1 (first day oxytocin or placebo was administered)Population: Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.
Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.
Outcome measures
| Measure |
Oxytocin
n=26 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=26 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Perceived Trust Scores on a 1-7 Likert Scale
|
4.65 units on a scale
Standard Deviation 1.47
|
4.73 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Day 1 (first day oxytocin or placebo was administered)Population: Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.
Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.
Outcome measures
| Measure |
Oxytocin
n=26 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=26 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Perceived Empathy Scores on a 1-7 Likert Scale
|
4.46 units on a scale
Standard Deviation 1.39
|
4.27 units on a scale
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Day 1 (first day oxytocin or placebo was administered)Population: Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.
Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.
Outcome measures
| Measure |
Oxytocin
n=26 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=26 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Perceived Preference Scores on a 1-7 Likert Scale
|
5.04 units on a scale
Standard Deviation 1.40
|
5.04 units on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Day 1 (first day oxytocin or placebo was administered)Population: Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in this analysis. Thus, only 52 participants were included in this analysis.
Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.
Outcome measures
| Measure |
Oxytocin
n=26 Participants
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=26 Participants
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Perceived Rejection Scores on a 1-7 Likert Scale
|
3.35 units on a scale
Standard Deviation 1.41
|
3.65 units on a scale
Standard Deviation 1.29
|
Adverse Events
Oxytocin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=27 participants at risk
Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once
|
Placebo
n=27 participants at risk
Matched placebo nasal spray
Placebo: Matched placebo nasal spray
|
|---|---|---|
|
Nervous system disorders
Jitteriness/restlessness
|
14.8%
4/27
|
18.5%
5/27
|
|
Nervous system disorders
Anxiety
|
11.1%
3/27
|
11.1%
3/27
|
|
Nervous system disorders
Dry mouth
|
7.4%
2/27
|
7.4%
2/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place