Trial Outcomes & Findings for Target Engagement for Oxytocin: Dose Ranging Study (NCT NCT02498236)

NCT ID: NCT02498236

Last Updated: 2019-01-31

Results Overview

This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

Baseline, 1 Week

Results posted on

2019-01-31

Participant Flow

Participant milestones

Participant milestones
Measure
8IU Oxytocin
Subjects received either 8IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
12IU Oxytocin
Subjects received either 12IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
24IU Oxytocin
Subjects received either 24IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
36IU Oxytocin
Subjects received either 36IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
48IU Oxytocin
Subjects received either 48IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
60IU Oxytocin
Subjects received either 60IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
72IU Oxytocin
Subjects received either 72IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
84IU Oxytocin
Subjects received either 84IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
Overall Study
STARTED
6
6
6
6
7
6
7
7
Overall Study
Randomized
6
6
6
6
7
6
7
7
Overall Study
COMPLETED
5
6
6
6
6
6
6
6
Overall Study
NOT COMPLETED
1
0
0
0
1
0
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
8IU Oxytocin
Subjects received either 8IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
12IU Oxytocin
Subjects received either 12IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
24IU Oxytocin
Subjects received either 24IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
36IU Oxytocin
Subjects received either 36IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
48IU Oxytocin
Subjects received either 48IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
60IU Oxytocin
Subjects received either 60IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
72IU Oxytocin
Subjects received either 72IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
84IU Oxytocin
Subjects received either 84IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
Overall Study
Did not show for testing
1
0
0
0
0
0
0
1
Overall Study
Equipment failure
0
0
0
0
0
0
1
0
Overall Study
Withdrawal by Subject
0
0
0
0
1
0
0
0

Baseline Characteristics

Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
8IU Oxytocin
n=5 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
12IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
24IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
36IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
48IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
60IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
72IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
84IU Oxytocin
n=6 Participants
Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
Total
n=47 Participants
Total of all reporting groups
Age, Continuous
44.6 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
45.3 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
42.2 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
45.5 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
43.3 Years
STANDARD_DEVIATION 10.0 • n=21 Participants
45.2 Years
STANDARD_DEVIATION 9.8 • n=8 Participants
37.2 Years
STANDARD_DEVIATION 11.3 • n=8 Participants
43.0 Years
STANDARD_DEVIATION 9.8 • n=24 Participants
42.9 Years
STANDARD_DEVIATION 9.4 • n=42 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
16 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Sex: Female, Male
Male
3 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
31 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
10 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
6 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
37 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
5 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
19 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
White
1 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
3 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
4 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
23 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
1 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
2 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=7 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=5 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=4 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=21 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=8 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=24 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
0 Participants
n=42 Participants • Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population.
Region of Enrollment
United States
5 participants
n=5 Participants
6 participants
n=7 Participants
6 participants
n=5 Participants
6 participants
n=4 Participants
6 participants
n=21 Participants
6 participants
n=8 Participants
6 participants
n=8 Participants
6 participants
n=24 Participants
47 participants
n=42 Participants

PRIMARY outcome

Timeframe: Baseline, 1 Week

This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions.

Outcome measures

Outcome measures
Measure
8IU Oxytocin
n=6 Participants
8 international units (IU) of Oxytocin
12IU Oxytocin
n=6 Participants
12 international units (IU) of Oxytocin
24IU Oxytocin
n=6 Participants
24 international units (IU) of Oxytocin
36IU Oxytocin
n=6 Participants
36 international units (IU) of Oxytocin
48IU Oxytocin
n=6 Participants
48 international units (IU) of Oxytocin
60IU Oxytocin
n=6 Participants
60 international units (IU) of Oxytocin
72IU Oxytocin
n=6 Participants
72 international units (IU) of Oxytocin
84IU Oxytocin
n=5 Participants
84 international units (IU) of Oxytocin
Placebo
n=47 Participants
Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of oxytocin (OT) they received.
Mu Suppression on EEG
-0.0907 log10 transformed ratio (Hz)
Standard Deviation 0.10515
-0.0632 log10 transformed ratio (Hz)
Standard Deviation 0.08206
-0.0542 log10 transformed ratio (Hz)
Standard Deviation 0.07471
-0.1153 log10 transformed ratio (Hz)
Standard Deviation 0.07699
-0.1333 log10 transformed ratio (Hz)
Standard Deviation 0.06625
-0.0459 log10 transformed ratio (Hz)
Standard Deviation 0.03514
-0.1101 log10 transformed ratio (Hz)
Standard Deviation 0.02654
-0.0149 log10 transformed ratio (Hz)
Standard Deviation 0.08074
-0.0726 log10 transformed ratio (Hz)
Standard Deviation 0.10331

PRIMARY outcome

Timeframe: Baseline, 1 Week

This primary outcome measure is pupil size recorded during a facial affect identification task. In this task, participants view faces portraying happy, afraid, or neutral faces; scrambled images of the faces were also shown. There were 64 trials: 16 trials per each image type. The primary measure was the difference in pupil size averaged over the happy and fearful faces from the scrambled face condition. A positive value indicates greater pupil dilation relative to the scrambled face; a negative value indicates greater pupil constriction relative to the scrambled face. Baseline was defined as the median pupil width 1 second prior to stimulus onset. Pupil sizes during each trial were baseline-corrected by dividing them by baseline median width. Resulting pupil size timecourses were averaged within-subject for each type of stimulus (happy, afraid, neutral, scrambled). The primary dependent variable was computed by taking the average of the change in pupil size between 1 and 3 s.

Outcome measures

Outcome measures
Measure
8IU Oxytocin
n=6 Participants
8 international units (IU) of Oxytocin
12IU Oxytocin
n=6 Participants
12 international units (IU) of Oxytocin
24IU Oxytocin
n=6 Participants
24 international units (IU) of Oxytocin
36IU Oxytocin
n=6 Participants
36 international units (IU) of Oxytocin
48IU Oxytocin
n=6 Participants
48 international units (IU) of Oxytocin
60IU Oxytocin
n=6 Participants
60 international units (IU) of Oxytocin
72IU Oxytocin
n=6 Participants
72 international units (IU) of Oxytocin
84IU Oxytocin
n=5 Participants
84 international units (IU) of Oxytocin
Placebo
n=47 Participants
Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of oxytocin (OT) they received.
Pupil Dilation While Observing Faces
.0074 arbitrary units
Standard Deviation .00669
.0347 arbitrary units
Standard Deviation .03395
-.0089 arbitrary units
Standard Deviation 04525
.0153 arbitrary units
Standard Deviation .02317
-.0011 arbitrary units
Standard Deviation .02862
.0103 arbitrary units
Standard Deviation .01498
.0299 arbitrary units
Standard Deviation .03634
.0073 arbitrary units
Standard Deviation .03469
.0134 arbitrary units
Standard Deviation .03195

Adverse Events

8IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

12IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

24IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

36IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

48IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

60IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

72IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

84IU Oxytocin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen R. Marder

University of California, Los Angeles

Phone: 3104783711

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place