Trial Outcomes & Findings for The Role of Vasopressin in the Social Deficits of Autism (NCT NCT01962870)
NCT ID: NCT01962870
Last Updated: 2019-05-24
Results Overview
Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Baseline; Week 4
Results posted on
2019-05-24
Participant Flow
This study was conducted in the Autism and Developmental Disorders Clinic in the Division of Child and Adolescent Psychiatry at Stanford University. Recruitment began in December 2013 and ended in May 2017.
68 participants signed the consent form and enrolled in the study. Of those 68 participants, 27 participants did not meet the eligibility criteria for the study and 11 participants declined to participate prior to randomization. 30 participants were randomized.
Participant milestones
| Measure |
Placebo
Placebo Nasal Spray
Placebo
|
Vasopressin
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Vasopressin in the Social Deficits of Autism
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 4Population: Participants who completed the protocol are included in the analysis.
Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
|
10.8 units on a scale
Standard Error 2.11
|
17.6 units on a scale
Standard Error 1.37
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included.
Higher Scores on the CGI severity scale mean more greater social and communication deficits (Range 1-7)
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment.
|
0.712 units on a scale
Standard Error 0.202
|
0.873 units on a scale
Standard Error 0.126
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. Range 0-28.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.
|
-1.28 units on a scale
Standard Error 1.24
|
4.04 units on a scale
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities (Range: 0-42).
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.
|
-7.19 units on a scale
Standard Error 1.81
|
3.10 units on a scale
Standard Error 2.42
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data were analyzed.
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 |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
|
21.3 units on a scale
Standard Error 3.18
|
17.2 units on a scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data were analyzed.
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 |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
|
9.14 units on a scale
Standard Error 2.68
|
17.9 units on a scale
Standard Error 1.66
|
SECONDARY outcome
Timeframe: Baseline through Week 4Population: Participants who completed the protocol are included in the analysis.
Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Fever
|
1 participants
|
2 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Cough
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Body Ache
|
0 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
|
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
|
4 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Increased Motor Activity
|
0 participants
|
4 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Depressive Affect
|
1 participants
|
2 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Headache
|
0 participants
|
2 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Drowsiness
|
3 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Decreased Motor Activity
|
2 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Aggression
|
1 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Akathisia
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Head Banging
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Dizziness
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Lethargy/Tiredness
|
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
|
4 participants
|
3 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Dry Mouth
|
3 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Blurred Vision
|
1 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Ear Infection
|
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
Sore Throat
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Cold Sore
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Decreased Appetite
|
5 participants
|
4 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Nausea/Vomiting
|
2 participants
|
2 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Constipation
|
0 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Diarrhea
|
1 participants
|
0 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Increased Urination
|
1 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Bed Wetting
|
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 Rash
|
1 participants
|
1 participants
|
|
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
Bug Bite
|
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 Burn
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 4Population: Participants with available data are included in the analysis.
Count of participants reporting an increase of aggression during treatment compared to baseline (pretreatment).
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline on the Overt Aggression Scale (OAS) During Treatment.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants who completed the protocol are included in the analysis.
Sitting heart rate (beats per minute).
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Heart Rate After Treatment.
|
7.5 Beats per minute
Standard Error 4.43
|
1.9 Beats per minute
Standard Error 3.87
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data were included in analysis.
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 |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Irritability Baseline
|
14.00 units on a scale
Standard Deviation 10.23
|
8.29 units on a scale
Standard Deviation 7.40
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Irritability Week 4
|
8.38 units on a scale
Standard Deviation 7.23
|
6.24 units on a scale
Standard Deviation 7.05
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Lethargy Baseline
|
14.77 units on a scale
Standard Deviation 10.69
|
10.76 units on a scale
Standard Deviation 6.32
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Lethargy Week 4
|
12.77 units on a scale
Standard Deviation 9.81
|
7.41 units on a scale
Standard Deviation 6.88
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Stereotypy Baseline
|
5.08 units on a scale
Standard Deviation 5.36
|
5.18 units on a scale
Standard Deviation 3.88
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Stereotypy Week 4
|
4.54 units on a scale
Standard Deviation 4.91
|
3.53 units on a scale
Standard Deviation 3.59
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Hyperactivity Baseline
|
21.38 units on a scale
Standard Deviation 9.17
|
16.00 units on a scale
Standard Deviation 11.69
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Hyperactivity Week 4
|
14.54 units on a scale
Standard Deviation 7.34
|
12.29 units on a scale
Standard Deviation 9.06
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Inappropriate Speech Baseline
|
4.62 units on a scale
Standard Deviation 3.74
|
3.94 units on a scale
Standard Deviation 2.86
|
|
Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.
Inappropriate Speech Week 4
|
3.69 units on a scale
Standard Deviation 3.52
|
3.41 units on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data were analyzed.
Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Parent Rated Pediatric Quality of Life (PedQL) Inventory Scores During Treatment.
Baseline
|
57.14 units on a scale
Standard Deviation 16.67
|
64.53 units on a scale
Standard Deviation 13.86
|
|
Change From Baseline in Parent Rated Pediatric Quality of Life (PedQL) Inventory Scores During Treatment.
Week 4
|
65.96 units on a scale
Standard Deviation 14.93
|
74.52 units on a scale
Standard Deviation 15.38
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Not all participants were able to fully complete the measure so not all of the numbers analyzed are the same.
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 |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scales Second Edition (VABS-II) - Social and Communication Subscales During Treatment.
Baseline Social Standard Score
|
61.33 units on a scale
Standard Deviation 13.93
|
71.08 units on a scale
Standard Deviation 14.38
|
|
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scales Second Edition (VABS-II) - Social and Communication Subscales During Treatment.
Week 4 Social Standard Score
|
62.25 units on a scale
Standard Deviation 7.78
|
79.67 units on a scale
Standard Deviation 16.83
|
|
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scales Second Edition (VABS-II) - Social and Communication Subscales During Treatment.
Baseline Communication Standard Score
|
75.67 units on a scale
Standard Deviation 13.57
|
74.77 units on a scale
Standard Deviation 8.60
|
|
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scales Second Edition (VABS-II) - Social and Communication Subscales During Treatment.
Week 4 Communication Standard Score
|
77.40 units on a scale
Standard Deviation 10.55
|
81.12 units on a scale
Standard Deviation 14.26
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Clinical chemistry labs(sodium, potassium, chloride)
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Labs (NA+, K+, Cl-) During Treatment.
Change From Baseline in Sodium
|
0.15 mmol/L
Standard Error 0.72
|
0.24 mmol/L
Standard Error 0.63
|
|
Change From Baseline in Clinical Chemistry Labs (NA+, K+, Cl-) During Treatment.
Change from Baseline in Potassium
|
0.06 mmol/L
Standard Error 0.13
|
0.15 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Clinical Chemistry Labs (NA+, K+, Cl-) During Treatment.
Change from Baseline on Chloride
|
-0.31 mmol/L
Standard Error 0.64
|
1.0 mmol/L
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Data were not not collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Data were not not collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Sitting Systolic and Diastolic blood pressure.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Blood Pressure After Treatment
Change from Baseline in Systolic Blood Pressure
|
-1.1 mmHG
Standard Error 2.89
|
5.5 mmHG
Standard Error 2.53
|
|
Change From Baseline in Blood Pressure After Treatment
Change from Baseline in Diastolic Blood Pressure
|
-1.8 mmHG
Standard Error 2.39
|
3.2 mmHG
Standard Error 2.09
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Body Weight After Treatment.
|
0.2 kilograms
Standard Error 0.34
|
0.3 kilograms
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants with available data are included in the analysis.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Body Temperature After Treatment
|
-0.2 Degrees (Farenheit)
Standard Error 0.19
|
0.2 Degrees (Farenheit)
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: 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 |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in a Developmental Neuropsychological Assessment, Second Edition. (NEPSY-II) Affect Recognition Scores During Treatment.
|
-2.58 units on a scale
Standard Error 1.9
|
0.094 units on a scale
Standard Error 2.20
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants with available data were included in the analysis.
There are no clinical laboratory tests that establish a normative range for vasopressin. Measurements prior to treatment were intended to evaluate vasopressin level as a predictor of response. Plasma vasopressin levels post treatment were not quantified. Baseline vasopressin levels are included in the outcome data below.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 Participants
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
Change From Baseline in Plasma Vasopressin Levels During Treatment.
|
1.28 pg/ml
Standard Error 0.29
|
1.32 pg/ml
Standard Error 0.25
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Vasopressin
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=13 participants at risk
Placebo Nasal Spray
Placebo
|
Vasopressin
n=17 participants at risk
Vasopressin Nasal Spray
Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
|
|---|---|---|
|
General disorders
Fever
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
11.8%
2/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Cough
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Body Ache
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Psychiatric disorders
Excitement/Agitation
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
23.5%
4/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Insomnia
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
23.5%
4/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Increased Motor Activity
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
23.5%
4/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Psychiatric disorders
Depressive Affect
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
11.8%
2/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
11.8%
2/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Drowsiness
|
23.1%
3/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Decreased Motor Activity
|
15.4%
2/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Psychiatric disorders
Aggression
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Psychiatric disorders
Head Banging
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Nervous system disorders
Lethargy/Tiredness
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Nasal Congestion
|
30.8%
4/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
17.6%
3/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Dry Mouth
|
23.1%
3/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Eye disorders
Blurred Vision
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Ear and labyrinth disorders
Ear Infection
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Runny Nose
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Sore Throat
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Skin and subcutaneous tissue disorders
Cold Sore
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Gastrointestinal disorders
Decreased Appetite
|
38.5%
5/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
23.5%
4/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
15.4%
2/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
11.8%
2/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Increased Urination
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
General disorders
Bed Wetting
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Skin and subcutaneous tissue disorders
Bug Bite
|
0.00%
0/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
5.9%
1/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
|
Skin and subcutaneous tissue disorders
Skin Burn
|
7.7%
1/13 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
0.00%
0/17 • 4 weeks
Dosage Record Treatment Emergent Symptom Scale (DOTES) and Overt Aggression Scale (OAS) were used to assess side effects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place