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Trial record 28 of 1482 for:    child psychiatry

Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01624194
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : June 6, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism
Interventions Drug: Oxytocin nasal spray
Drug: Placebo
Enrollment 54
Recruitment Details

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.

Pre-assignment Details 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.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description Oxytocin nasal spray: 24IU twice daily (BID) (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks. Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Period Title: Overall Study
Started 16 18
Completed 14 18
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             1             0
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray Total
Hide Arm/Group Description Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks. Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks. Total of all reporting groups
Overall Number of Baseline Participants 16 18 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
<=18 years
16
 100.0%
18
 100.0%
34
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Female
2
  12.5%
4
  22.2%
6
  17.6%
Male
14
  87.5%
14
  77.8%
28
  82.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Caucasian
6
  37.5%
8
  44.4%
14
  41.2%
Asian
4
  25.0%
5
  27.8%
9
  26.5%
Other
6
  37.5%
5
  27.8%
11
  32.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 18 participants 34 participants
16
 100.0%
18
 100.0%
34
 100.0%
1.Primary Outcome
Title Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.
Hide Description Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.73  (2.64) 3.18  (2.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
Comments [Not Specified]
Method General Linear Model (GLM)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Hide Description Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.
Time Frame Baseline through Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 18
Measure Type: Number
Unit of Measure: participants
Cold Symptoms 0 1
Fever 0 1
Cough 1 0
Headache 1 0
Insomnia 1 1
Excitement/Agitation 1 2
Depressive Affect 0 1
Labile Mood 1 1
Silly Behavior 1 0
More Distractible 1 0
Nasal Congestion 3 0
Epistaxis 1 0
Sneezing 0 1
Mouth Pain 0 1
Intranasal Swelling 1 0
Runny Nose 1 0
Blinking Eyes 0 1
Earache 0 1
Nasal Discomfort 0 1
Loose Stool 1 0
Constipation 1 0
Stomach Discomfort 0 1
Skin Cut 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Height.
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data are included in the analysis.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 17
Least Squares Mean (95% Confidence Interval)
Unit of Measure: cm
Baseline
134
(126 to 141)
129
(122 to 135)
Week 4
134
(127 to 142)
129
(122 to 136)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments A mixed-models analysis was used to compare between groups, and between baseline and Week 4.
4.Secondary Outcome
Title Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Hide Description 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.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data are included.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 18
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
0
   0.0%
0
   0.0%
Much Improved
3
  21.4%
3
  16.7%
Minimally Improved
2
  14.3%
5
  27.8%
No Change
9
  64.3%
10
  55.6%
Minimally Worse
0
   0.0%
0
   0.0%
Much Worse
0
   0.0%
0
   0.0%
Very Much Worse
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Hide Description 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.
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data are included.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 16 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Irritablity 13.20  (11.91) 13.94  (8.71)
Week 4 Irritability 8.86  (8.87) 11.78  (8.11)
Baseline Lethargy 14.13  (8.70) 11.7  (8.34)
Week 4 Lethargy 10.6  (4.07) 7.33  (6.30)
Baseline Stereotypy 5.69  (6.20) 5.61  (4.55)
Week 4 Stereotypy 4.86  (5.07) 5.50  (4.85)
Baseline Hyperactivity 15.00  (13.74) 23.28  (10.74)
Week 4 Hyperactivity 10.50  (10.17) 19.11  (9.68)
Baseline Inappropriate Speech 3.94  (3.28) 5.44  (3.99)
Week 4 Inappropriate Speech 2.86  (3.23) 4.17  (3.31)
6.Secondary Outcome
Title Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
Hide Description 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)
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.66  (3.05) 4.53  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3395
Comments [Not Specified]
Method General Linear Model (GLM)
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
Hide Description 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.
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data are included.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 9 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Social Standard Score 61.4  (12.82) 67.75  (12.45)
Week 4 Social Standard Score 66.11  (16.03) 70.92  (14.23)
Baseline Communication Standard Scores 66.91  (19.60) 71.80  (17.85)
Week 4 Communication Standard Scores 71.33  (11.43) 78.29  (19.12)
8.Secondary Outcome
Title Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.
Hide Description [Not Specified]
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for this outcome.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.
Hide Description [Not Specified]
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not not collected for this outcome.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.
Hide Description [Not Specified]
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not not collected for this outcome.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.
Hide Description

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.

Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 4 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Affect Recognition Score 10  (1.89) 9.43  (3.78)
Week 4 Affect Recognition Score 8.75  (1.5) 6.43  (4.08)
13.Secondary Outcome
Title Change From Baseline in Plasma Oxytocin Levels During Treatment.
Hide Description

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.

Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 11 15
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 8.82  (4.67) 8.66  (3.85)
Week 4 10.36  (3.57) 8.40  (3.57)
14.Secondary Outcome
Title Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.
Hide Description Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Only analyzed after 4 weeks.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.68  (3.32) 5.79  (2.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9757
Comments [Not Specified]
Method General Linear Model (GLM)
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Weight
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 14 17
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kilograms
Baseline
32.7
(27.0 to 39.5)
28.0
(23.5 to 33.2)
Week 4
33.5
(27.7 to 40.4)
28.4
(23.9 to 33.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments A mixed-models analysis was used to compare between groups, and between baseline and Week 4.
16.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data are included in the analysis.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 13 14
Least Squares Mean (95% Confidence Interval)
Unit of Measure: beats per minute
Baseline Sitting Heart Rate
92.5
(83.0 to 101.9)
92.7
(83.6 to 101.8)
Post 4 -Week Sitting Heart Rate
97.1
(87.7 to 106.5)
101.6
(92.5 to 110.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data are included in the analysis.
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Overall Number of Participants Analyzed 13 14
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
Baseline Systolic Blood Pressure, Sitting
104.2
(98.7 to 109.8)
101.0
(95.6 to 106.4)
Post 4 -Week Systolic Blood Pressure, Sitting
111.1
(105.5 to 116.6)
110.9
(105.6 to 116.3)
Baseline Diastolic Blood Pressure, Sitting
64.3
(59.0 to 69.6)
64.6
(59.4 to 69.7)
Post 4 -Week Diastolic Blood Pressure, Sitting
71.4
(66.1 to 76.7)
68.9
(63.8 to 74.1)
Baseline Systolic Blood Pressure, Standing
101.6
(95.2 to 108.1)
107.7
(101.5 to 113.9)
Post 4 -Week Systolic Blood Pressure, Standing
111.6
(105.2 to 118.1)
105.6
(99.4 to 111.9)
Baseline Diastolic Blood Pressure, Standing
63.3
(58.0 to 68.6)
68.2
(63.1 to 73.3)
Post 4 -Week Diastolic Blood Pressure, Standing
70.9
(65.6 to 76.2)
69.8
(64.7 to 74.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments For all blood pressure analyses.
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks. Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
All-Cause Mortality
Oxytocin Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   11/14 (78.57%)   12/18 (66.67%) 
Ear and labyrinth disorders     
Earache   0/14 (0.00%)  1/18 (5.56%) 
Eye disorders     
Blinking Eyes   0/14 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Loose Stool   1/14 (7.14%)  0/18 (0.00%) 
Constipation   1/14 (7.14%)  0/18 (0.00%) 
Stomach Discomfort   0/14 (0.00%)  1/18 (5.56%) 
General disorders     
Cold Symptoms   0/14 (0.00%)  1/18 (5.56%) 
Fever   0/14 (0.00%)  1/18 (5.56%) 
Cough   1/14 (7.14%)  0/18 (0.00%) 
Nasal Congestion   3/14 (21.43%)  0/18 (0.00%) 
Epistaxis   1/14 (7.14%)  0/18 (0.00%) 
Sneezing   0/14 (0.00%)  1/18 (5.56%) 
Mouth Pain   0/14 (0.00%)  1/18 (5.56%) 
Intranasal Swelling   1/14 (7.14%)  0/18 (0.00%) 
Runny Nose   1/14 (7.14%)  0/18 (0.00%) 
Nasal Discomfort   0/14 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Headache   1/14 (7.14%)  0/18 (0.00%) 
Psychiatric disorders     
Insomnia   1/14 (7.14%)  1/18 (5.56%) 
Excitement/Agitation   1/14 (7.14%)  2/18 (11.11%) 
Depressive Affect   0/14 (0.00%)  1/18 (5.56%) 
Labile Mood   1/14 (7.14%)  1/18 (5.56%) 
Silly Behavior   1/14 (7.14%)  0/18 (0.00%) 
More Distractible   1/14 (7.14%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Cut   0/14 (0.00%)  2/18 (11.11%) 
Indicates events were collected by systematic assessment
The final sample was 84% male and was not powered to detect sex differences in treatment response. Participants were permitted to take other medications during the intervention. Many of our outcome measures relied on parent report.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Antonio Y. Hardan, MD
Organization: Stanford University
Phone: (650) 736-1235
Responsible Party: Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier: NCT01624194     History of Changes
Other Study ID Numbers: SU-12132011-8827
First Submitted: June 18, 2012
First Posted: June 20, 2012
Results First Submitted: September 20, 2017
Results First Posted: June 6, 2018
Last Update Posted: July 15, 2019