Trial Outcomes & Findings for Single Dose Intranasal Oxytocin and Cognitive Effects in Autism (NCT NCT02493426)
NCT ID: NCT02493426
Last Updated: 2023-01-23
Results Overview
Social Cognition Task-- We are reporting raw score (# of correct responses) Minimum value is 0 and maximum value is 28. A higher score means better performance / outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-01-23
Participant Flow
Participant milestones
| Measure |
Placebo Then Intranasal Oxytocin
Saline Nasal spray designed to look and feel like the drug intervention
Placebo
|
Intranasal Oxytocin Then Placebo
Oxytocin nasal spray designed to look as seem exactly like Placebo
Intranasal Oxytocin
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Then Intranasal Oxytocin
Saline Nasal spray designed to look and feel like the drug intervention
Placebo
|
Intranasal Oxytocin Then Placebo
Oxytocin nasal spray designed to look as seem exactly like Placebo
Intranasal Oxytocin
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Single Dose Intranasal Oxytocin and Cognitive Effects in Autism
Baseline characteristics by cohort
| Measure |
All Participants
n=27 Participants
All participants (cross-over design)
|
|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksSocial Cognition Task-- We are reporting raw score (# of correct responses) Minimum value is 0 and maximum value is 28. A higher score means better performance / outcome.
Outcome measures
| Measure |
Placebo Then Oxytocin
n=14 Participants
Saline Nasal spray designed to look and feel like the drug intervention
Placebo
|
Intranasal Oxytocin Then Placebo
n=12 Participants
Oxytocin nasal spray designed to look as seem exactly like Placebo
Intranasal Oxytocin
|
|---|---|---|
|
Reading the Mind in the Eyes Task (RMET)
Intervention Period 1
|
18.07 total raw score
Standard Deviation 4.48
|
18.08 total raw score
Standard Deviation 2.47
|
|
Reading the Mind in the Eyes Task (RMET)
Intervention Period 2
|
17.86 total raw score
Standard Deviation 4.77
|
18.09 total raw score
Standard Deviation 3.08
|
PRIMARY outcome
Timeframe: 2 weeksCognitive Rigidity Task for \>10 years old-- Time to name attribute of stimulus requested; minimum time is 0, there is no maximum time. Lower score is better.
Outcome measures
| Measure |
Placebo Then Oxytocin
n=10 Participants
Saline Nasal spray designed to look and feel like the drug intervention
Placebo
|
Intranasal Oxytocin Then Placebo
n=8 Participants
Oxytocin nasal spray designed to look as seem exactly like Placebo
Intranasal Oxytocin
|
|---|---|---|
|
Rapid Automatized Naming (RAN)
Symbolic: Intervention Period 1
|
18.08 naming time (seconds)
Standard Deviation 4.69
|
16.13 naming time (seconds)
Standard Deviation 6.21
|
|
Rapid Automatized Naming (RAN)
Symbolic: Intervention Period 2
|
17.98 naming time (seconds)
Standard Deviation 5.71
|
15.28 naming time (seconds)
Standard Deviation 4.63
|
|
Rapid Automatized Naming (RAN)
Non-symbolic: Intervention Period 1
|
27.93 naming time (seconds)
Standard Deviation 6.02
|
24.13 naming time (seconds)
Standard Deviation 6.31
|
|
Rapid Automatized Naming (RAN)
Non-symbolic: Intervention Period 2
|
28.70 naming time (seconds)
Standard Deviation 6.95
|
23.31 naming time (seconds)
Standard Deviation 7.16
|
PRIMARY outcome
Timeframe: 2 weeksTask Performance with Physiological Data. We reported the raw score - total number correct. Minimum is 0, maximum is 12. Higher score means better performance / outcome.
Outcome measures
| Measure |
Placebo Then Oxytocin
n=14 Participants
Saline Nasal spray designed to look and feel like the drug intervention
Placebo
|
Intranasal Oxytocin Then Placebo
n=12 Participants
Oxytocin nasal spray designed to look as seem exactly like Placebo
Intranasal Oxytocin
|
|---|---|---|
|
Dynamic Affect Recognition Evaluation (DARE)
Intervention Period 1
|
8.5 total raw score
Standard Deviation 3.32
|
8.45 total raw score
Standard Deviation 3.67
|
|
Dynamic Affect Recognition Evaluation (DARE)
Intervention Period 2
|
8.36 total raw score
Standard Deviation 3.43
|
8.92 total raw score
Standard Deviation 4.01
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Intranasal Oxytocin
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Saline Nasal spray designed to look and feel like the drug intervention, then Placebo
|
Intranasal Oxytocin
n=27 participants at risk
Oxytocin nasal spray designed to look as seem exactly like Placebo, then Intranasal Oxytocin
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Injury, poisoning and procedural complications
Bloody nose
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Fatigue
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Injury, poisoning and procedural complications
Mouth pain
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Greater awakeness
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Energized
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Lightheadedness
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Nervous system disorders
Greater calmness
|
14.8%
4/27 • Number of events 4 • 6 weeks per participant
|
7.4%
2/27 • Number of events 2 • 6 weeks per participant
|
|
Nervous system disorders
Less anxiety
|
11.1%
3/27 • Number of events 3 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Nervous system disorders
Perseveration
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
0.00%
0/27 • 6 weeks per participant
|
|
General disorders
Less flexibility
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Loss of appetite
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Nervous system disorders
Agitation
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Nervous system disorders
Drowsiness
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
0.00%
0/27 • 6 weeks per participant
|
|
General disorders
Dry mouth
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
0.00%
0/27 • 6 weeks per participant
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Chill
|
0.00%
0/27 • 6 weeks per participant
|
3.7%
1/27 • Number of events 1 • 6 weeks per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place