Trial Outcomes & Findings for Autism Oxytocin Brain Project (NCT NCT03033784)
NCT ID: NCT03033784
Last Updated: 2021-01-12
Results Overview
Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4
Results posted on
2021-01-12
Participant Flow
Study participants were recruited from a list of participants in a prior study who agreed to be contacted for future studies. Study procedures were conducted at Emory University Hospital in Atlanta, Georgia. Participant enrollment began May 10, 2017 and all study activities were completed on October 3, 2018.
Participant milestones
| Measure |
Dose Order: Placebo, 8 International Units (IU), 24IU, 48IU
Participants with ASD randomized to receive the placebo first, followed by an 8IU of oxytocin, then 24IU dose of oxytocin, and a 48IU dose of oxytocin last.
|
Dose Order: 24IU, 8IU, Placebo, 48IU
Participants with ASD randomized to receive a 24IU dose of oxytocin, followed by an 8IU of oxytocin, then the placebo, and a 48IU dose of oxytocin last.
|
Dose Order: 24IU, Placebo, 8IU, 48IU
Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by the placebo, then 8IU dose of oxytocin, and a 48IU dose of oxytocin last.
|
Dose Order: 48IU, Placebo, 8IU, 24IU
Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by the placebo, then an 8IU dose of oxytocin, and a 24IU dose of oxytocin last.
|
Dose Order: 8IU, 24IU, Placebo, 48IU
Participants with ASD randomized to receive an 8IU dose of oxytocin first, followed by a 24IU dose of oxytocin, then the placebo, and a 48IU dose of oxytocin last.
|
Dose Order: 48IU, 24IU, 8IU, Placebo
Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by a 24IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.
|
Dose Order: Placebo, 48IU, 24IU, 8IU
Participants with ASD randomized to receive the placebo first, followed by a 48IU of oxytocin, then 24IU dose of oxytocin, and an 8IU dose of oxytocin last.
|
Dose Order: Placebo, 24IU, 48IU, 8IU
Participants with ASD randomized to receive the placebo first, followed by a 24IU of oxytocin, then a 48IU dose of oxytocin, and an 8IU dose of oxytocin last.
|
Dose Order: 48IU, 24IU, Placebo, 8IU
Participants with ASD randomized to receive a dose of 48IU of oxytocin first, followed by a 24IU of oxytocin, then the placebo, and an 8IU dose of oxytocin last.
|
Dose Order: 8IU, 24IU, 48IU, Placebo
Participants with ASD randomized to receive an 8IU of oxytocin first, followed by an 24IU of oxytocin, then 48IU dose of oxytocin, the placebo last.
|
Dose Order: 24IU, 48IU, 8IU, Placebo
Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by a 48IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.
|
Dose Order: 48IU, 8IU, Placebo, 24IU
Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by an 8IU of oxytocin, then the placebo, and a 24IU dose of oxytocin last.
|
Healthy Controls Receiving the Placebo
Healthy controls (persons without ASD) received the placebo rather than any oxytocin. The healthy controls only attended one clinical visit, per the study protocol.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
2
|
4
|
4
|
3
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
19
|
|
Overall Study
Clinical Visit 2
|
9
|
2
|
4
|
4
|
3
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
17
|
|
Overall Study
Clinical Visit 3
|
9
|
1
|
4
|
4
|
3
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
Clinical Visit 4
|
9
|
1
|
4
|
4
|
3
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
9
|
1
|
4
|
4
|
3
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Dose Order: Placebo, 8 International Units (IU), 24IU, 48IU
Participants with ASD randomized to receive the placebo first, followed by an 8IU of oxytocin, then 24IU dose of oxytocin, and a 48IU dose of oxytocin last.
|
Dose Order: 24IU, 8IU, Placebo, 48IU
Participants with ASD randomized to receive a 24IU dose of oxytocin, followed by an 8IU of oxytocin, then the placebo, and a 48IU dose of oxytocin last.
|
Dose Order: 24IU, Placebo, 8IU, 48IU
Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by the placebo, then 8IU dose of oxytocin, and a 48IU dose of oxytocin last.
|
Dose Order: 48IU, Placebo, 8IU, 24IU
Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by the placebo, then an 8IU dose of oxytocin, and a 24IU dose of oxytocin last.
|
Dose Order: 8IU, 24IU, Placebo, 48IU
Participants with ASD randomized to receive an 8IU dose of oxytocin first, followed by a 24IU dose of oxytocin, then the placebo, and a 48IU dose of oxytocin last.
|
Dose Order: 48IU, 24IU, 8IU, Placebo
Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by a 24IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.
|
Dose Order: Placebo, 48IU, 24IU, 8IU
Participants with ASD randomized to receive the placebo first, followed by a 48IU of oxytocin, then 24IU dose of oxytocin, and an 8IU dose of oxytocin last.
|
Dose Order: Placebo, 24IU, 48IU, 8IU
Participants with ASD randomized to receive the placebo first, followed by a 24IU of oxytocin, then a 48IU dose of oxytocin, and an 8IU dose of oxytocin last.
|
Dose Order: 48IU, 24IU, Placebo, 8IU
Participants with ASD randomized to receive a dose of 48IU of oxytocin first, followed by a 24IU of oxytocin, then the placebo, and an 8IU dose of oxytocin last.
|
Dose Order: 8IU, 24IU, 48IU, Placebo
Participants with ASD randomized to receive an 8IU of oxytocin first, followed by an 24IU of oxytocin, then 48IU dose of oxytocin, the placebo last.
|
Dose Order: 24IU, 48IU, 8IU, Placebo
Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by a 48IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.
|
Dose Order: 48IU, 8IU, Placebo, 24IU
Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by an 8IU of oxytocin, then the placebo, and a 24IU dose of oxytocin last.
|
Healthy Controls Receiving the Placebo
Healthy controls (persons without ASD) received the placebo rather than any oxytocin. The healthy controls only attended one clinical visit, per the study protocol.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Anxiety related to MRI scanner
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Autism Oxytocin Brain Project
Baseline characteristics by cohort
| Measure |
Autism Spectrum Disorder (ASD)
n=32 Participants
Male participants diagnosed with ASD received 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) or a placebo during 4 study visits. The order in which the participant received the placebo and three different doses of oxytocin (8, 24, or 48IU) was randomly assigned.
|
Healthy Control
n=19 Participants
Age matched healthy males received a placebo intranasal spray (12 puffs, 6 per nostril) during one study visit
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.97 years
STANDARD_DEVIATION 5.83 • n=5 Participants
|
30.84 years
STANDARD_DEVIATION 6.50 • n=7 Participants
|
29.67 years
STANDARD_DEVIATION 6.09 • 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
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4Population: This analysis includes participants with complete data for all visits. Two participants withdrew and data from another participant were not able to be analyzed due to technical problems during the MRI.
Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.
Outcome measures
| Measure |
Placebo in ASD Participants
n=30 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=30 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=30 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=30 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
n=17 Participants
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)
|
0.338 z-scores rsFC salience-visual
Standard Deviation 0.331
|
0.400 z-scores rsFC salience-visual
Standard Deviation 0.261
|
0.428 z-scores rsFC salience-visual
Standard Deviation 0.248
|
0.522 z-scores rsFC salience-visual
Standard Deviation 0.216
|
0.591 z-scores rsFC salience-visual
Standard Deviation 0.214
|
PRIMARY outcome
Timeframe: Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4Population: This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.
BOLD activity level was assessed via fMRI during completion of the face perception task (FPT) of emotional and neutral faces. BOLD scores are reported on a z-scale, with the mean, standard deviation and the minimum and the maximum. This refers to the non-thresholded z-scores that are obtained for each dose before conducting small volume correction analysis.
Outcome measures
| Measure |
Placebo in ASD Participants
n=26 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=28 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=29 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=25 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
n=17 Participants
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Occipital Fusiform Gyrus
|
0.684501 z-scores
Interval -1.489766 to 2.596111
|
-0.459616 z-scores
Interval -2.702162 to 3.262832
|
0.206772 z-scores
Interval -2.308452 to 2.749471
|
0.32432 z-scores
Interval -3.60349 to 2.583284
|
0.795348 z-scores
Interval -2.271818 to 3.046978
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Left Accumbens
|
1.430518 z-scores
Interval -1.04353 to 2.928855
|
-1.177278 z-scores
Interval -3.294369 to 0.402549
|
0.984787 z-scores
Interval -1.104499 to 1.914929
|
-0.777588 z-scores
Interval -3.409385 to 1.37446
|
1.059391 z-scores
Interval -0.255741 to 2.069515
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Left Caudate
|
0.377711 z-scores
Interval -1.217217 to 2.477899
|
0.185452 z-scores
Interval -1.960983 to 2.223351
|
0.58712 z-scores
Interval -0.836157 to 2.637696
|
0.00862 z-scores
Interval -3.291056 to 2.095994
|
1.613145 z-scores
Interval -1.51541 to 2.993093
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Frontal Orbital Cortex
|
0.444076 z-scores
Interval -3.980701 to 4.066222
|
0.084622 z-scores
Interval -3.465221 to 3.349507
|
0.434074 z-scores
Interval -2.768946 to 3.143204
|
-0.042926 z-scores
Interval -3.315568 to 2.746546
|
1.116102 z-scores
Interval -1.707134 to 3.869851
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Left Amygdala
|
-0.148364 z-scores
Interval -2.244867 to 1.857259
|
0.328634 z-scores
Interval -1.946766 to 2.938312
|
0.435674 z-scores
Interval -1.569945 to 2.837412
|
0.659752 z-scores
Interval -2.03181 to 2.689729
|
2.130943 z-scores
Interval 0.564661 to 3.349099
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Insular Cortex
|
0.078993 z-scores
Interval -2.741794 to 2.651302
|
0.814225 z-scores
Interval -0.964688 to 3.001415
|
1.280621 z-scores
Interval -1.535613 to 3.649256
|
0.791272 z-scores
Interval -1.838989 to 4.374804
|
0.869933 z-scores
Interval -1.937001 to 2.842933
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Occipital Fusiform Gyrus
|
0.336816 z-scores
Interval -1.818473 to 3.575764
|
0.664895 z-scores
Interval -1.735978 to 3.302326
|
1.007465 z-scores
Interval -2.025182 to 3.262868
|
1.263083 z-scores
Interval -1.714918 to 3.640724
|
0.926976 z-scores
Interval -1.643682 to 3.201217
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Left Laterobasal Amygdala
|
-0.50816 z-scores
Interval -2.706088 to 2.065712
|
0.11396 z-scores
Interval -1.289767 to 3.043139
|
0.276778 z-scores
Interval -1.192876 to 1.852493
|
0.561114 z-scores
Interval -1.731715 to 2.259484
|
1.910744 z-scores
Interval -0.995564 to 3.208958
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Right Laterobasal Amygdala
|
-0.516251 z-scores
Interval -2.699315 to 1.637606
|
0.143468 z-scores
Interval -1.877897 to 2.858212
|
0.6247 z-scores
Interval -2.617959 to 3.03048
|
0.230971 z-scores
Interval -1.722826 to 2.324656
|
1.905216 z-scores
Interval -0.464664 to 3.187876
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Right Caudate
|
0.050791 z-scores
Interval -1.771317 to 2.670673
|
0.132704 z-scores
Interval -1.920536 to 2.824892
|
0.025731 z-scores
Interval -1.896249 to 1.525611
|
-0.292749 z-scores
Interval -4.148703 to 2.352553
|
1.470176 z-scores
Interval -0.804718 to 3.345023
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Right Amygdala
|
-0.119579 z-scores
Interval -1.766533 to 2.24458
|
0.735094 z-scores
Interval -1.151499 to 3.192013
|
1.018509 z-scores
Interval -2.083258 to 3.03048
|
0.554755 z-scores
Interval -1.860525 to 2.394795
|
1.683817 z-scores
Interval -0.853004 to 3.205723
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Right Amygdala
|
0.505732 z-scores
Interval -1.552433 to 2.498199
|
0.040877 z-scores
Interval -1.880963 to 2.043247
|
0.928212 z-scores
Interval -0.763867 to 2.593808
|
-0.922439 z-scores
Interval -4.184451 to 1.664002
|
1.078819 z-scores
Interval -0.886149 to 2.589554
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Right Accumbens
|
0.821772 z-scores
Interval -0.495173 to 1.957395
|
-0.129955 z-scores
Interval -2.583269 to 2.113898
|
0.565472 z-scores
Interval -1.049526 to 2.281018
|
-0.776844 z-scores
Interval -2.016895 to 0.594082
|
0.683166 z-scores
Interval -0.677622 to 2.492205
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Left Amygdala
|
-0.192095 z-scores
Interval -2.406393 to 1.693166
|
0.512198 z-scores
Interval -1.087271 to 3.282288
|
0.368682 z-scores
Interval -1.412992 to 2.378465
|
1.091867 z-scores
Interval -1.250699 to 2.76721
|
2.214728 z-scores
Interval 0.952909 to 3.208958
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Left Amygdala
|
0.13828 z-scores
Interval -1.928161 to 2.436266
|
-0.477983 z-scores
Interval -3.085623 to 2.149772
|
0.561367 z-scores
Interval -1.616188 to 2.625552
|
-0.62126 z-scores
Interval -3.873271 to 2.413952
|
1.542177 z-scores
Interval -0.461272 to 2.734072
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Insular Cortex
|
0.3329 z-scores
Interval -2.675982 to 2.832457
|
0.462527 z-scores
Interval -1.660037 to 2.811897
|
1.049595 z-scores
Interval -1.273595 to 3.276281
|
0.145474 z-scores
Interval -2.786065 to 3.332985
|
0.779819 z-scores
Interval -2.346668 to 3.176402
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Cingulate Gyrus, Anterior Division
|
-0.13682 z-scores
Interval -2.575577 to 2.913227
|
0.663003 z-scores
Interval -1.584421 to 2.818681
|
0.89113 z-scores
Interval -1.245631 to 3.40183
|
0.239665 z-scores
Interval -2.31224 to 2.701743
|
1.267345 z-scores
Interval -1.801961 to 3.327014
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Occipital Fusiform Gyrus
|
0.547858 z-scores
Interval -1.359913 to 3.171797
|
0.377043 z-scores
Interval -1.896795 to 3.5329
|
0.830858 z-scores
Interval -2.054403 to 3.167927
|
0.981023 z-scores
Interval -1.285486 to 3.026658
|
0.967798 z-scores
Interval -1.651371 to 3.226593
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Left Laterobasal Amygdala
|
-0.477913 z-scores
Interval -2.687634 to 1.870421
|
-0.085989 z-scores
Interval -1.700797 to 2.776355
|
0.31737 z-scores
Interval -0.895359 to 1.987475
|
-0.039061 z-scores
Interval -2.717465 to 2.075508
|
1.879398 z-scores
Interval -1.170747 to 3.377844
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Right Laterobasal Amygdala
|
-0.203773 z-scores
Interval -2.527037 to 1.933879
|
-0.247527 z-scores
Interval -2.365987 to 2.928211
|
0.482033 z-scores
Interval -2.461489 to 2.6846
|
-0.291652 z-scores
Interval -2.0339 to 1.932592
|
1.808126 z-scores
Interval -0.99204 to 3.175681
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Left Accumbens
|
2.022323 z-scores
Interval -0.153325 to 3.383661
|
-1.05875 z-scores
Interval -2.861125 to 0.649379
|
1.752678 z-scores
Interval -1.440897 to 2.841185
|
-0.373102 z-scores
Interval -2.431424 to 1.562321
|
1.120372 z-scores
Interval -0.295477 to 2.693954
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Right Caudate
|
-0.500704 z-scores
Interval -2.558909 to 2.218523
|
0.916936 z-scores
Interval -1.741694 to 3.073441
|
1.197835 z-scores
Interval -1.169374 to 2.704396
|
0.246921 z-scores
Interval -2.510118 to 2.197111
|
1.354862 z-scores
Interval -0.860082 to 3.293443
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Right Hippocampus
|
-0.015598 z-scores
Interval -2.428018 to 3.698757
|
-0.093067 z-scores
Interval -3.202297 to 3.501489
|
0.716515 z-scores
Interval -2.60632 to 2.458323
|
-0.011004 z-scores
Interval -1.741691 to 1.793119
|
1.203561 z-scores
Interval -0.834364 to 3.154893
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Right Amygdala
|
0.147144 z-scores
Interval -1.452559 to 2.200656
|
0.567225 z-scores
Interval -0.989488 to 3.187283
|
1.009125 z-scores
Interval -2.175977 to 2.6846
|
0.031841 z-scores
Interval -1.604876 to 1.963714
|
1.60342 z-scores
Interval -0.71754 to 3.148343
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Right Accumbens
|
0.893013 z-scores
Interval -0.681809 to 1.831226
|
-0.307024 z-scores
Interval -2.341113 to 2.385545
|
1.396064 z-scores
Interval -1.57792 to 3.083594
|
-0.421539 z-scores
Interval -1.611225 to 0.916681
|
0.996732 z-scores
Interval -0.406555 to 2.566207
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Left Caudate
|
-0.188575 z-scores
Interval -2.121857 to 2.886153
|
0.971035 z-scores
Interval -0.785839 to 2.831995
|
1.498338 z-scores
Interval 0.132905 to 3.00282
|
0.470775 z-scores
Interval -2.18889 to 1.988801
|
1.577967 z-scores
Interval -1.278729 to 2.883603
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Emotion versus Neutral, Left Hippocampus
|
-0.057242 z-scores
Interval -2.656764 to 2.174723
|
-0.154759 z-scores
Interval -3.093637 to 2.431969
|
0.471703 z-scores
Interval -2.465754 to 2.760711
|
0.150852 z-scores
Interval -2.583713 to 2.787405
|
1.211722 z-scores
Interval -1.678622 to 3.78067
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Negative Emotions versus Neutral, Cingulate Gyrus, Anterior Division
|
-0.189082 z-scores
Interval -2.496925 to 2.594132
|
1.001123 z-scores
Interval -0.867178 to 3.086144
|
1.064596 z-scores
Interval -1.394323 to 3.537169
|
0.906276 z-scores
Interval -2.548369 to 4.187496
|
1.07742 z-scores
Interval -1.531522 to 2.899168
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Insular Cortex
|
0.347824 z-scores
Interval -3.086408 to 2.294047
|
-0.758427 z-scores
Interval -2.614224 to 0.614738
|
-0.602304 z-scores
Interval -2.746292 to 1.613434
|
0.33747 z-scores
Interval -2.70115 to 2.9478
|
-0.540874 z-scores
Interval -3.423316 to 2.087243
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Frontal Orbital Cortex
|
0.517829 z-scores
Interval -2.3038 to 3.234023
|
-0.339727 z-scores
Interval -2.099626 to 2.850896
|
0.133334 z-scores
Interval -2.105783 to 2.2979
|
0.51544 z-scores
Interval -2.51943 to 3.32401
|
0.504016 z-scores
Interval -2.080812 to 3.234903
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Occipital Fusiform Gyrus
|
3.427291 z-scores
Interval -0.812082 to 5.631112
|
3.556448 z-scores
Interval -1.039342 to 6.120963
|
3.403614 z-scores
Interval -1.445628 to 5.572412
|
3.39230 z-scores
Interval -1.0047 to 5.80665
|
3.322934 z-scores
Interval -0.978423 to 6.224413
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Left Accumbens
|
0.324295 z-scores
Interval -1.939803 to 1.759384
|
-0.358148 z-scores
Interval -1.451141 to 0.765259
|
-0.76235 z-scores
Interval -1.917312 to 0.928076
|
-0.364131 z-scores
Interval -1.405679 to 1.852745
|
-0.859178 z-scores
Interval -2.026179 to 1.316851
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Right Caudate
|
0.086391 z-scores
Interval -1.634846 to 1.335388
|
-0.820473 z-scores
Interval -2.670037 to 0.688685
|
0.536007 z-scores
Interval -0.75045 to 2.122765
|
-0.602492 z-scores
Interval -2.543713 to 2.199534
|
0.232223 z-scores
Interval -2.707574 to 2.410349
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Right Hippocampus
|
0.86138 z-scores
Interval -1.352965 to 4.348929
|
-0.391579 z-scores
Interval -1.868284 to 3.961795
|
0.194145 z-scores
Interval -1.941021 to 4.12766
|
0.485382 z-scores
Interval -2.754611 to 3.198802
|
0.613169 z-scores
Interval -2.431345 to 5.088185
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Right Amygdala
|
1.047957 z-scores
Interval -0.621127 to 3.190074
|
-0.638315 z-scores
Interval -1.963881 to 1.061985
|
0.175908 z-scores
Interval -1.389825 to 1.977887
|
1.302074 z-scores
Interval -1.287299 to 2.737782
|
1.701371 z-scores
Interval -0.697901 to 4.212626
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Right Accumbens
|
-0.316604 z-scores
Interval -1.951857 to 0.911325
|
-0.567634 z-scores
Interval -1.789596 to 0.482181
|
-0.418176 z-scores
Interval -1.775193 to 1.027106
|
-0.556553 z-scores
Interval -1.956654 to 2.058268
|
-1.532579 z-scores
Interval -2.425838 to -0.526067
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Left Caudate
|
0.241254 z-scores
Interval -1.046636 to 1.514177
|
-0.698518 z-scores
Interval -1.975601 to 0.583743
|
-0.041339 z-scores
Interval -1.46476 to 1.240659
|
-0.280602 z-scores
Interval -2.330866 to 2.582442
|
0.017432 z-scores
Interval -2.115235 to 2.203946
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Left Hippocampus
|
0.699955 z-scores
Interval -2.416034 to 4.59093
|
-0.72534 z-scores
Interval -1.926855 to 4.494122
|
-0.033878 z-scores
Interval -1.662279 to 4.135666
|
0.295781 z-scores
Interval -2.781685 to 3.806
|
0.632196 z-scores
Interval -2.667728 to 5.220928
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Left Amygdala
|
0.221233 z-scores
Interval -1.532993 to 1.726722
|
-0.631298 z-scores
Interval -1.901488 to 0.466238
|
0.078968 z-scores
Interval -1.932001 to 1.317286
|
1.120718 z-scores
Interval -1.259113 to 2.66841
|
1.65022 z-scores
Interval -1.359844 to 3.559769
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Happy versus Neutral, Frontal Orbital Cortex
|
0.39487 z-scores
Interval -3.876791 to 3.910739
|
-0.195753 z-scores
Interval -3.703273 to 3.396273
|
0.243287 z-scores
Interval -2.268647 to 2.754313
|
-0.625216 z-scores
Interval -4.775246 to 3.053599
|
1.04841 z-scores
Interval -1.382502 to 4.049732
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Cingulate Gyrus, Anterior Division
|
0.313911 z-scores
Interval -2.50618 to 2.058421
|
-0.59443 z-scores
Interval -2.122833 to 1.013119
|
-0.922999 z-scores
Interval -2.996872 to 2.020612
|
0.03105 z-scores
Interval -2.13638 to 2.62367
|
-0.573381 z-scores
Interval -3.103699 to 2.334144
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Left Laterobasal Amygdala
|
-0.003581 z-scores
Interval -1.595989 to 2.935086
|
-0.46194 z-scores
Interval -1.821512 to 0.953573
|
0.347864 z-scores
Interval -1.570765 to 1.521856
|
1.06647 z-scores
Interval -1.74681 to 2.66841
|
1.341538 z-scores
Interval -1.84355 to 3.69492
|
|
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Face versus Fixation, Right Laterobasal Amygdala
|
0.817701 z-scores
Interval -0.488433 to 1.900966
|
-0.80763 z-scores
Interval -1.895006 to 2.793559
|
0.57701 z-scores
Interval -0.796838 to 2.303261
|
0.989042 z-scores
Interval -2.810703 to 3.013389
|
1.03517 z-scores
Interval -2.307756 to 3.598735
|
PRIMARY outcome
Timeframe: Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4Population: This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.
BOLD activity in social-emotional brain regions during the perception of emotional facial videos were measured during the ball-game task. Mean percent change in contrast of parameter estimates in anatomical regions of interest are presented here. A positive value indicates increased BOLD activity while a negative value indicates decreased BOLD activity.
Outcome measures
| Measure |
Placebo in ASD Participants
n=22 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=22 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=22 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=22 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
n=16 Participants
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Negative Feedback, Right Amygdala
|
0.3141 percent change in contrast
Standard Error 0.0621
|
0.1118 percent change in contrast
Standard Error 0.0452
|
0.1979 percent change in contrast
Standard Error 0.0490
|
0.3576 percent change in contrast
Standard Error 0.0641
|
0.3823 percent change in contrast
Standard Error 0.0796
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive Feedback, Anterior Cingulate (Sphere)
|
0.2774 percent change in contrast
Standard Error 0.0854
|
0.0996 percent change in contrast
Standard Error 0.0564
|
0.1526 percent change in contrast
Standard Error 0.0711
|
0.2343 percent change in contrast
Standard Error 0.0696
|
0.1218 percent change in contrast
Standard Error 0.0594
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive - Negative Feedback, Right Caudate
|
0.0072 percent change in contrast
Standard Error 0.0376
|
0.0205 percent change in contrast
Standard Error 0.0278
|
0.1188 percent change in contrast
Standard Error 0.0440
|
-0.0452 percent change in contrast
Standard Error 0.0527
|
-0.0057 percent change in contrast
Standard Error 0.0576
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Negative Feedback, Left Amygdala
|
0.2568 percent change in contrast
Standard Error 0.0563
|
0.1379 percent change in contrast
Standard Error 0.0494
|
0.1631 percent change in contrast
Standard Error 0.0430
|
0.3304 percent change in contrast
Standard Error 0.0658
|
0.3502 percent change in contrast
Standard Error 0.0738
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Negative Feedback, Right Laterobasal Amygdala
|
0.1724 percent change in contrast
Standard Error 0.0476
|
0.0921 percent change in contrast
Standard Error 0.0379
|
0.0984 percent change in contrast
Standard Error 0.0362
|
0.2569 percent change in contrast
Standard Error 0.0666
|
0.2258 percent change in contrast
Standard Error 0.0479
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Negative Feedback, Left Laterobasal Amygdala
|
0.1512 percent change in contrast
Standard Error 0.0493
|
0.0739 percent change in contrast
Standard Error 0.0472
|
0.1094 percent change in contrast
Standard Error 0.0417
|
0.2014 percent change in contrast
Standard Error 0.0715
|
0.2717 percent change in contrast
Standard Error 0.0555
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Negative Feedback, Ventral Anterior Insula (Sphere)
|
0.1830 percent change in contrast
Standard Error 0.0801
|
0.0311 percent change in contrast
Standard Error 0.0574
|
-0.0575 percent change in contrast
Standard Error 0.0661
|
0.1866 percent change in contrast
Standard Error 0.0872
|
0.0815 percent change in contrast
Standard Error 0.0651
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Negative Feedback, Anterior Cingulate (Sphere)
|
0.2604 percent change in contrast
Standard Error 0.1109
|
0.0953 percent change in contrast
Standard Error 0.0630
|
0.0419 percent change in contrast
Standard Error 0.0497
|
0.3214 percent change in contrast
Standard Error 0.0780
|
0.1406 percent change in contrast
Standard Error 0.0525
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive Feedback, Frontal Orbital Cortex
|
0.2263 percent change in contrast
Standard Error 0.0760
|
0.1338 percent change in contrast
Standard Error 0.0360
|
0.1826 percent change in contrast
Standard Error 0.0509
|
0.1859 percent change in contrast
Standard Error 0.0575
|
0.2301 percent change in contrast
Standard Error 0.0388
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive Feedback, Ventral Tegmental Area
|
0.2412 percent change in contrast
Standard Error 0.0738
|
0.1010 percent change in contrast
Standard Error 0.0528
|
0.1889 percent change in contrast
Standard Error 0.0769
|
0.1770 percent change in contrast
Standard Error 0.0879
|
0.0848 percent change in contrast
Standard Error 0.0607
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive Feedback, Right Caudate
|
0.2540 percent change in contrast
Standard Error 0.0823
|
0.1114 percent change in contrast
Standard Error 0.0512
|
0.2605 percent change in contrast
Standard Error 0.0753
|
0.2824 percent change in contrast
Standard Error 0.0728
|
0.3004 percent change in contrast
Standard Error 0.0602
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive Feedback, Right Nucleus Accumbens
|
0.1139 percent change in contrast
Standard Error 0.0675
|
0.1017 percent change in contrast
Standard Error 0.0557
|
0.1779 percent change in contrast
Standard Error 0.0575
|
0.1341 percent change in contrast
Standard Error 0.0642
|
0.2092 percent change in contrast
Standard Error 0.0669
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive - Negative Feedback, Anterior Cingulate (Sphere)
|
0.0175 percent change in contrast
Standard Error 0.0501
|
0.0084 percent change in contrast
Standard Error 0.0431
|
0.1156 percent change in contrast
Standard Error 0.0592
|
-0.0996 percent change in contrast
Standard Error 0.0443
|
-0.0320 percent change in contrast
Standard Error 0.0439
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive - Negative Feedback, Frontal Orbital Cortex
|
0.0142 percent change in contrast
Standard Error 0.0428
|
0.081 percent change in contrast
Standard Error 0.0481
|
0.0826 percent change in contrast
Standard Error 0.0412
|
-0.0957 percent change in contrast
Standard Error 0.0443
|
0.0286 percent change in contrast
Standard Error 0.0359
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive - Negative Feedback, Ventral Tegmental Area
|
0.1417 percent change in contrast
Standard Error 0.0448
|
-0.0175 percent change in contrast
Standard Error 0.0391
|
0.0302 percent change in contrast
Standard Error 0.0416
|
-0.0940 percent change in contrast
Standard Error 0.0810
|
-0.0457 percent change in contrast
Standard Error 0.0555
|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Human Minus Computer, Positive - Negative Feedback, Right Nucleus Accumbens
|
-0.0277 percent change in contrast
Standard Error 0.0354
|
0.0528 percent change in contrast
Standard Error 0.0354
|
0.1174 percent change in contrast
Standard Error 0.0352
|
-0.0615 percent change in contrast
Standard Error 0.0417
|
-0.0737 percent change in contrast
Standard Error 0.0666
|
PRIMARY outcome
Timeframe: Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray)Population: Only participants with ASD had blood drawn for plasma oxytocin concentrations. This analysis includes participants who provided a blood sample (one refused to give a sample).
Plasma concentration of oxytocin prior to administration of study intervention and after administration of study intervention will be compared between the different dose levels and placebo. Plasma concentration of oxytocin is expected to increase following administration of intranasal oxytocin.
Outcome measures
| Measure |
Placebo in ASD Participants
n=30 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=30 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=30 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=30 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Oxytocin Plasma Concentration
Prior to spray
|
8.09 picogram/milliliter
Standard Deviation 3.97
|
11.17 picogram/milliliter
Standard Deviation 6.99
|
9.06 picogram/milliliter
Standard Deviation 3.45
|
9.72 picogram/milliliter
Standard Deviation 9.40
|
—
|
|
Oxytocin Plasma Concentration
After spray
|
7.75 picogram/milliliter
Standard Deviation 3.67
|
14.36 picogram/milliliter
Standard Deviation 9.28
|
17.52 picogram/milliliter
Standard Deviation 8.41
|
20.86 picogram/milliliter
Standard Deviation 12.66
|
—
|
SECONDARY outcome
Timeframe: Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4Population: This analysis includes participants with ASD who completed the videotaped interview. One participant declined to be videotaped and is not included in this analysis.
Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Values between the different treatment conditions will be assessed to study the effect of intranasal oxytocin on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant, specifically as the amount of smiling behavior displayed by participants. Larger values indicate that participants are smiling more frequently.
Outcome measures
| Measure |
Placebo in ASD Participants
n=30 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=30 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=30 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=30 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Rate of Smiling During Global Clinical Interview
|
0.954 Smiles per minute
Standard Deviation 0.724
|
0.954 Smiles per minute
Standard Deviation 0.801
|
1.013 Smiles per minute
Standard Deviation 0.810
|
1.015 Smiles per minute
Standard Deviation 0.744
|
—
|
SECONDARY outcome
Timeframe: Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4Population: This analysis includes participants with ASD who had usable data for this outcome. There were difficulties with the eye tracking technology inside the MRI scanner and tracking of the pupil was not successful at all times. Healthy controls did not participate in the eye tracker portion of the study.
Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Visual fixation between different treatment conditions will be assessed in ASD participants.
Outcome measures
| Measure |
Placebo in ASD Participants
n=14 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=21 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=14 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=13 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Milliseconds of Visual Fixation
|
91786.05 milliseconds
Standard Deviation 65288.71
|
82503.23 milliseconds
Standard Deviation 48615.57
|
134913.00 milliseconds
Standard Deviation 55067.12
|
130600.90 milliseconds
Standard Deviation 66305.70
|
—
|
SECONDARY outcome
Timeframe: Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4Population: Among participants with autism who completed the study, two participants had outlying data and were removed from this analysis.Two healthy controls did not complete the SLT due to time constraints.
During the SLT, participants complete an implicit association test using faces and words. The faces that are presented in this task are partners' faces with whom participants played during the ball-game inside the MRI scanner. In this task, there are congruent blocks where neutral faces of "positive" partners are presented with friendly words and neutral faces of "negative" partners are presented with unfriendly words. During incongruent blocks, neutral faces of "positive" partners are presented with unfriendly words and neutral faces of "negative" partners are presented with friendly words. Participants match the face or the word to one of two categories. Longer reaction time indicates difficulty with selecting a category. Longer reaction time in incongruent trials signifies implicit biases were formed for the positive and negative players such that "positive" partners from the ball-game are now perceived as friendly and "negative" partners are now perceived as unfriendly.
Outcome measures
| Measure |
Placebo in ASD Participants
n=29 Participants
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=29 Participants
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=29 Participants
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=29 Participants
Participants receiving 48IU of oxytocin
|
Healthy Controls Receiving Placebo
n=15 Participants
Healthy controls received the placebo spray only
|
|---|---|---|---|---|---|
|
Social Learning Test (SLT) Reaction Time
Congruent Blocks
|
939.43 milliseconds
Standard Deviation 605.79
|
972.08 milliseconds
Standard Deviation 950.41
|
905.99 milliseconds
Standard Deviation 741.22
|
896.63 milliseconds
Standard Deviation 679.50
|
762.72 milliseconds
Standard Deviation 335.81
|
|
Social Learning Test (SLT) Reaction Time
Incongruent Blocks
|
969.17 milliseconds
Standard Deviation 730.30
|
960.41 milliseconds
Standard Deviation 745.84
|
920.23 milliseconds
Standard Deviation 622.83
|
921.90 milliseconds
Standard Deviation 650.23
|
791.65 milliseconds
Standard Deviation 410.01
|
|
Social Learning Test (SLT) Reaction Time
Training Blocks
|
790.49 milliseconds
Standard Deviation 757.66
|
800.25 milliseconds
Standard Deviation 922.21
|
765.53 milliseconds
Standard Deviation 754.48
|
761.89 milliseconds
Standard Deviation 782.89
|
655.27 milliseconds
Standard Deviation 499.78
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
8IU of Oxytocin Spray
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
24IU of Oxytocin Spray
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
48IU of Oxytocin Spray
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=48 participants at risk
Participants receiving the placebo
|
8IU of Oxytocin Spray
n=32 participants at risk
Participants receiving 8IU of oxytocin
|
24IU of Oxytocin Spray
n=32 participants at risk
Participants receiving 24IU of oxytocin
|
48IU of Oxytocin Spray
n=31 participants at risk
Participants receiving 48IU of oxytocin
|
|---|---|---|---|---|
|
General disorders
Lightheaded after spray
|
4.2%
2/48 • Number of events 2 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
6.2%
2/32 • Number of events 2 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
Vascular disorders
Blood pressure increase
|
2.1%
1/48 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.2%
1/31 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
General disorders
Headache
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
9.4%
3/32 • Number of events 3 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.2%
1/31 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
Eye disorders
Blurred vision
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
General disorders
Dizziness after spray and blood draw
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
General disorders
Drowsiness
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
6.2%
2/32 • Number of events 2 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
6.5%
2/31 • Number of events 2 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
General disorders
Temperature increase
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
Vascular disorders
Numb left hand
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nostril tingling after spray
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
General disorders
Frustration during MRI
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.1%
1/32 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/31 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Light coughing after spray
|
0.00%
0/48 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
0.00%
0/32 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
3.2%
1/31 • Number of events 1 • Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).
Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place