Trial Outcomes & Findings for The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders (NCT NCT01183221)
NCT ID: NCT01183221
Last Updated: 2021-04-15
Results Overview
Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
COMPLETED
PHASE2
30 participants
45 minutes after drug/placebo administration
2021-04-15
Participant Flow
Participant milestones
| Measure |
Syntocinon Then Placebo
One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
|
Placebo Then Syntocinon
Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon
|
|---|---|---|
|
First Dose
STARTED
|
15
|
15
|
|
First Dose
COMPLETED
|
15
|
15
|
|
First Dose
NOT COMPLETED
|
0
|
0
|
|
3 Weeks Wash Out
STARTED
|
15
|
15
|
|
3 Weeks Wash Out
COMPLETED
|
14
|
14
|
|
3 Weeks Wash Out
NOT COMPLETED
|
1
|
1
|
|
Second Dose
STARTED
|
14
|
14
|
|
Second Dose
COMPLETED
|
14
|
14
|
|
Second Dose
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Syntocinon Then Placebo
One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
|
Placebo Then Syntocinon
Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon
|
|---|---|---|
|
3 Weeks Wash Out
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Syntocinon Then Placebo
n=14 Participants
One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
|
Placebo Then Syntocinon
n=14 Participants
Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 45 minutes after drug/placebo administrationPopulation: The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points.
Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 45 minutes after oxytocin/placebo administrationPopulation: The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points.
Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant.
Outcome measures
Outcome data not reported
Adverse Events
Syntocinon
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Syntocinon
n=28 participants at risk
One dose 24IU (3 sprays/nostril) intranasal oxytocin,
|
Placebo
n=28 participants at risk
Intranasal Placebo
|
|---|---|---|
|
Ear and labyrinth disorders
Ringing Ears
|
0.00%
0/28
|
3.6%
1/28
|
|
General disorders
Headache
|
14.3%
4/28
|
7.1%
2/28
|
|
General disorders
Fatigue
|
7.1%
2/28
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.6%
1/28
|
0.00%
0/28
|
|
Endocrine disorders
Watery eyes
|
3.6%
1/28
|
7.1%
2/28
|
|
Skin and subcutaneous tissue disorders
Sore throat
|
0.00%
0/28
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Cold hand
|
0.00%
0/28
|
3.6%
1/28
|
|
General disorders
Dizzy
|
0.00%
0/28
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Burning in throat after nasal spray
|
7.1%
2/28
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Sinuses tender
|
7.1%
2/28
|
0.00%
0/28
|
|
Psychiatric disorders
Lack of focus
|
3.6%
1/28
|
7.1%
2/28
|
|
Musculoskeletal and connective tissue disorders
Felt body/joint pain
|
7.1%
2/28
|
7.1%
2/28
|
|
Reproductive system and breast disorders
Breasts tender
|
3.6%
1/28
|
0.00%
0/28
|
|
Psychiatric disorders
Difficulty sleeping
|
3.6%
1/28
|
0.00%
0/28
|
|
General disorders
Light headedness
|
0.00%
0/28
|
3.6%
1/28
|
|
Psychiatric disorders
Slowed thought process
|
3.6%
1/28
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
7.1%
2/28
|
7.1%
2/28
|
|
Ear and labyrinth disorders
Difficulty hearing
|
3.6%
1/28
|
3.6%
1/28
|
|
Cardiac disorders
Chest tightness
|
0.00%
0/28
|
3.6%
1/28
|
|
Gastrointestinal disorders
Mild diarrhea
|
3.6%
1/28
|
3.6%
1/28
|
Additional Information
Dr. Alexander Kolevzon
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place