Trial Outcomes & Findings for Intranasal Oxytocin Treatment for Social Deficits in Children With Autism (NCT NCT01624194)
NCT ID: NCT01624194
Last Updated: 2019-07-15
Results Overview
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline; Week 4
Results posted on
2019-07-15
Participant Flow
This study was conducted in the Autism and Developmental Disabilities Clinic in the Division of Child and Adolescent Psychiatry at Stanford University. Recruitment began in June 2012 and ended in April 2016. Participants were recruited through the Stanford Autism Research Registry, flyers posted in the community, posted online and special events.
54 subjects were consented and assessed for eligibility. 19 subjects were excluded (13 did not meet inclusion criteria and 6 declined to participate). Additionally, 1 subject allocated to oxytocin did not receive allocated intervention due to parent declining to participate.
Participant milestones
| Measure |
Oxytocin Nasal Spray
Oxytocin nasal spray: 24IU twice daily (BID) (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
14
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Oxytocin Nasal Spray
Oxytocin nasal spray: 24IU twice daily (BID) (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
Baseline characteristics by cohort
| Measure |
Oxytocin Nasal Spray
n=16 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 4Population: Participants who completed the protocol are included in the analysis.
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.
|
9.73 units on a scale
Standard Error 2.64
|
3.18 units on a scale
Standard Error 2.18
|
SECONDARY outcome
Timeframe: Baseline through Week 4Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Cold Symptoms
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Fever
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Cough
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Headache
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Insomnia
|
1 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Excitement/Agitation
|
1 participants
|
2 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Depressive Affect
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Labile Mood
|
1 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Silly Behavior
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
More Distractible
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Nasal Congestion
|
3 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Epistaxis
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Sneezing
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Mouth Pain
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Intranasal Swelling
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Runny Nose
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Blinking Eyes
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Earache
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Nasal Discomfort
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Loose Stool
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Constipation
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Stomach Discomfort
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Skin Cut
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=17 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Height.
Baseline
|
134 cm
Interval 126.0 to 141.0
|
129 cm
Interval 122.0 to 135.0
|
|
Change From Baseline in Height.
Week 4
|
134 cm
Interval 127.0 to 142.0
|
129 cm
Interval 122.0 to 136.0
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Participants with available data are included.
This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Very Much Improved
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Much Improved
|
3 Participants
|
3 Participants
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Minimally Improved
|
2 Participants
|
5 Participants
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
No Change
|
9 Participants
|
10 Participants
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Minimally Worse
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Much Worse
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Very Much Worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included.
Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=16 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Baseline Irritablity
|
13.20 units on a scale
Standard Deviation 11.91
|
13.94 units on a scale
Standard Deviation 8.71
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Week 4 Irritability
|
8.86 units on a scale
Standard Deviation 8.87
|
11.78 units on a scale
Standard Deviation 8.11
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Baseline Lethargy
|
14.13 units on a scale
Standard Deviation 8.70
|
11.7 units on a scale
Standard Deviation 8.34
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Week 4 Lethargy
|
10.6 units on a scale
Standard Deviation 4.07
|
7.33 units on a scale
Standard Deviation 6.30
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Baseline Stereotypy
|
5.69 units on a scale
Standard Deviation 6.20
|
5.61 units on a scale
Standard Deviation 4.55
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Week 4 Stereotypy
|
4.86 units on a scale
Standard Deviation 5.07
|
5.50 units on a scale
Standard Deviation 4.85
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Baseline Hyperactivity
|
15.00 units on a scale
Standard Deviation 13.74
|
23.28 units on a scale
Standard Deviation 10.74
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Week 4 Hyperactivity
|
10.50 units on a scale
Standard Deviation 10.17
|
19.11 units on a scale
Standard Deviation 9.68
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Baseline Inappropriate Speech
|
3.94 units on a scale
Standard Deviation 3.28
|
5.44 units on a scale
Standard Deviation 3.99
|
|
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Week 4 Inappropriate Speech
|
2.86 units on a scale
Standard Deviation 3.23
|
4.17 units on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants who completed the protocol are included in the analysis.
Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
|
1.66 units on a scale
Standard Error 3.05
|
4.53 units on a scale
Standard Error 2.21
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included.
Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=9 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=12 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
Baseline Social Standard Score
|
61.4 units on a scale
Standard Deviation 12.82
|
67.75 units on a scale
Standard Deviation 12.45
|
|
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
Week 4 Social Standard Score
|
66.11 units on a scale
Standard Deviation 16.03
|
70.92 units on a scale
Standard Deviation 14.23
|
|
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
Baseline Communication Standard Scores
|
66.91 units on a scale
Standard Deviation 19.60
|
71.80 units on a scale
Standard Deviation 17.85
|
|
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
Week 4 Communication Standard Scores
|
71.33 units on a scale
Standard Deviation 11.43
|
78.29 units on a scale
Standard Deviation 19.12
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Data were not collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Data were not not collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Data were not not collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data were included.
Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities. Scores can range from 1 to 19.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=4 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=7 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.
Baseline Affect Recognition Score
|
10 units on a scale
Standard Deviation 1.89
|
9.43 units on a scale
Standard Deviation 3.78
|
|
Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.
Week 4 Affect Recognition Score
|
8.75 units on a scale
Standard Deviation 1.5
|
6.43 units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Participants with available data were included in the analysis.
This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study. There are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=11 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=15 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Oxytocin Levels During Treatment.
Baseline
|
8.82 pg/mL
Standard Deviation 4.67
|
8.66 pg/mL
Standard Deviation 3.85
|
|
Change From Baseline in Plasma Oxytocin Levels During Treatment.
Week 4
|
10.36 pg/mL
Standard Deviation 3.57
|
8.40 pg/mL
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Only analyzed after 4 weeks.
Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.
|
5.68 units on a scale
Standard Error 3.32
|
5.79 units on a scale
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline; Week 4Outcome measures
| Measure |
Oxytocin Nasal Spray
n=14 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=17 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Weight
Baseline
|
32.7 kilograms
Interval 27.0 to 39.5
|
28.0 kilograms
Interval 23.5 to 33.2
|
|
Change From Baseline in Weight
Week 4
|
33.5 kilograms
Interval 27.7 to 40.4
|
28.4 kilograms
Interval 23.9 to 33.7
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=13 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=14 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Heart Rate
Baseline Sitting Heart Rate
|
92.5 beats per minute
Interval 83.0 to 101.9
|
92.7 beats per minute
Interval 83.6 to 101.8
|
|
Change From Baseline in Heart Rate
Post 4 -Week Sitting Heart Rate
|
97.1 beats per minute
Interval 87.7 to 106.5
|
101.6 beats per minute
Interval 92.5 to 110.6
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=13 Participants
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=14 Participants
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
Change From Baseline in Blood Pressure
Baseline Systolic Blood Pressure, Sitting
|
104.2 mmHg
Interval 98.7 to 109.8
|
101.0 mmHg
Interval 95.6 to 106.4
|
|
Change From Baseline in Blood Pressure
Post 4 -Week Systolic Blood Pressure, Sitting
|
111.1 mmHg
Interval 105.5 to 116.6
|
110.9 mmHg
Interval 105.6 to 116.3
|
|
Change From Baseline in Blood Pressure
Baseline Diastolic Blood Pressure, Sitting
|
64.3 mmHg
Interval 59.0 to 69.6
|
64.6 mmHg
Interval 59.4 to 69.7
|
|
Change From Baseline in Blood Pressure
Post 4 -Week Diastolic Blood Pressure, Sitting
|
71.4 mmHg
Interval 66.1 to 76.7
|
68.9 mmHg
Interval 63.8 to 74.1
|
|
Change From Baseline in Blood Pressure
Baseline Systolic Blood Pressure, Standing
|
101.6 mmHg
Interval 95.2 to 108.1
|
107.7 mmHg
Interval 101.5 to 113.9
|
|
Change From Baseline in Blood Pressure
Post 4 -Week Systolic Blood Pressure, Standing
|
111.6 mmHg
Interval 105.2 to 118.1
|
105.6 mmHg
Interval 99.4 to 111.9
|
|
Change From Baseline in Blood Pressure
Baseline Diastolic Blood Pressure, Standing
|
63.3 mmHg
Interval 58.0 to 68.6
|
68.2 mmHg
Interval 63.1 to 73.3
|
|
Change From Baseline in Blood Pressure
Post 4 -Week Diastolic Blood Pressure, Standing
|
70.9 mmHg
Interval 65.6 to 76.2
|
69.8 mmHg
Interval 64.7 to 74.9
|
Adverse Events
Oxytocin Nasal Spray
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Nasal Spray
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin Nasal Spray
n=14 participants at risk
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks.
|
Placebo Nasal Spray
n=18 participants at risk
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
|
|---|---|---|
|
General disorders
Cold Symptoms
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
General disorders
Fever
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
General disorders
Cough
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
Psychiatric disorders
Excitement/Agitation
|
7.1%
1/14 • 4 weeks
|
11.1%
2/18 • 4 weeks
|
|
Psychiatric disorders
Depressive Affect
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
Psychiatric disorders
Labile Mood
|
7.1%
1/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
Psychiatric disorders
Silly Behavior
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
Psychiatric disorders
More Distractible
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
General disorders
Nasal Congestion
|
21.4%
3/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
General disorders
Epistaxis
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
General disorders
Sneezing
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
General disorders
Mouth Pain
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
General disorders
Intranasal Swelling
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
General disorders
Runny Nose
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
Eye disorders
Blinking Eyes
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
General disorders
Nasal Discomfort
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
Gastrointestinal disorders
Loose Stool
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • 4 weeks
|
0.00%
0/18 • 4 weeks
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/14 • 4 weeks
|
5.6%
1/18 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Cut
|
0.00%
0/14 • 4 weeks
|
11.1%
2/18 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place