Autism
Conditions
Brief summary
Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.
Detailed description
In recent years, the neuropeptide oxytocin (OT) has been implicated in a wide range of social behaviors including attachment bonds, emotion recognition, eye gaze to social cues, and memory for social information. Social impairments represent one of the most intractable features of autism, and evidence now suggests that OT biology is dysregulated in individuals with this disorder. The central aim of the research outlined here is to test whether OT administration to children with autism increases their quality and quantity of social interactions and enhances their ability to process emotional and social information. Findings from initial single-dose OT administration studies in teenaged and adult males with autism have shown improvement in some aspects of social functioning, but replication and extension to well-controlled treatment trials with younger male and female subjects is necessary to evaluate effectiveness. We therefore aim to investigate the effect of intranasal OT on social cognition and behavior immediately following a single-dose (24IU) and following a 4-week period of OT (24IU BID) administration in a sample of 50 subjects with autism aged 6 to 12 years. The primary outcome for this study is change in social behavior, as determined by parent ratings on the Social Responsiveness Scale (SRS) after the 4-week treatment period. Secondary outcomes are changes in functioning on laboratory-based measures of social behavior and cognition following single-dose and 4-week OT administration. Research in a small study sample (N=13) also identified treatment responders and non-responders to a single-dose of OT. Thus, we also aim to identify biological and cognitive and behavioral variables (i.e., pretreatment levels of social functioning and pretreatment plasma hormone levels) that may influence treatment response efficacy in our larger study sample. On completion of the 4-week treatment period all subjects will have the option of participating in another 4-week double-blind trial in which they will be switched to the alternate nasal spray to that which they previously received. They will then undergo a fourth and final assessment time-point using the same testing procedures as outlined above on completion of the 4-week dosing. By providing subjects with the option of participating in a second 4-week treatment trial, all subjects will have an opportunity to receive the active oxytocin nasal spray. We also will be able to examine any ongoing effects of oxytocin treatment in the group receiving placebo during the second 4-week administration period. Subjects not willing to take part in the second trial will exit the study and will be referred to their treating physician.
Interventions
DRUGOxytocin nasal spray
24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice daily for 4-weeks.
DRUGPlacebo
3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11 months) * Intelligence Quotient \> 40 * Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview - Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria * Clinical Global Impression severity rating of 4 or higher * Care provider who can reliably bring subject to clinic visits, provide trustworthy ratings, and interacts with the subject on a regular basis * Stable medications for at least 4 weeks * No planned changes in psychosocial interventions during the trial * Willingness to provide blood samples.
Exclusion criteria
* Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder * Regular nasal obstruction or nosebleeds * Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology) * Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate) * A genetic abnormality (e.g., Fragile X Syndrome) * Significant hearing or vision impairments * Habitually drinks large volumes of water * Pregnancy, breastfeeding, or child birth within the last 6 months * Sexually active females not using a reliable method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | Baseline; Week 4 | Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Height. | Baseline; Week 4 | — |
| Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Baseline to Week 4 | 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. |
| Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline; Week 4 | 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. |
| Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Baseline; Week 4 | 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) |
| Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Baseline; Week 4 | 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. |
| Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment. | Up to 4 weeks | — |
| Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment. | Baseline; Week 4 | — |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Baseline through Week 4 | Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used. |
| Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment. | Up to 4 weeks | — |
| Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment. | Baseline; Week 4 | 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. |
| Change From Baseline in Plasma Oxytocin Levels During Treatment. | Up to 4 weeks | 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. |
| Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment. | Baseline; Week 4 | Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129) |
| Change From Baseline in Weight | Baseline; Week 4 | — |
| Change From Baseline in Heart Rate | Baseline; Week 4 | — |
| Change From Baseline in Blood Pressure | Baseline; Week 4 | — |
| Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment. | Up to 4 weeks | — |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Nasal Spray Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks. | 16 |
| Placebo Nasal Spray Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks. | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Oxytocin Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 18 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 5 Participants | 11 Participants |
| Region of Enrollment United States | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 18 |
| other Total, other adverse events | 11 / 14 | 12 / 18 |
| serious Total, serious adverse events | 0 / 14 | 0 / 18 |
Outcome results
Primary
Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.
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
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | 9.73 units on a scale | Standard Error 2.64 |
| Placebo Nasal Spray | Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | 3.18 units on a scale | Standard Error 2.18 |
p-value: 0.0275General Linear Model (GLM)
Secondary
Change From Baseline in Blood Pressure
Time frame: Baseline; Week 4
Population: Participants with available data are included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Diastolic Blood Pressure, Standing | 70.9 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Baseline Systolic Blood Pressure, Standing | 101.6 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Baseline Systolic Blood Pressure, Sitting | 104.2 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Systolic Blood Pressure, Sitting | 111.1 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Baseline Diastolic Blood Pressure, Sitting | 64.3 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Diastolic Blood Pressure, Sitting | 71.4 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Systolic Blood Pressure, Standing | 111.6 mmHg |
| Oxytocin Nasal Spray | Change From Baseline in Blood Pressure | Baseline Diastolic Blood Pressure, Standing | 63.3 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Diastolic Blood Pressure, Standing | 69.8 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Diastolic Blood Pressure, Sitting | 68.9 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Baseline Systolic Blood Pressure, Standing | 107.7 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Baseline Systolic Blood Pressure, Sitting | 101.0 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Baseline Diastolic Blood Pressure, Standing | 68.2 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Systolic Blood Pressure, Sitting | 110.9 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Post 4 -Week Systolic Blood Pressure, Standing | 105.6 mmHg |
| Placebo Nasal Spray | Change From Baseline in Blood Pressure | Baseline Diastolic Blood Pressure, Sitting | 64.6 mmHg |
p-value: >0.05Mixed Models Analysis
Secondary
Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.
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
Population: Participants with available data were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Placebo Nasal Spray | Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment. | Baseline Affect Recognition Score | 9.43 units on a scale | Standard Deviation 3.78 |
| Placebo Nasal Spray | Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment. | Week 4 Affect Recognition Score | 6.43 units on a scale | Standard Deviation 4.08 |
Secondary
Change From Baseline in Heart Rate
Time frame: Baseline; Week 4
Population: Participants with available data are included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Heart Rate | Baseline Sitting Heart Rate | 92.5 beats per minute |
| Oxytocin Nasal Spray | Change From Baseline in Heart Rate | Post 4 -Week Sitting Heart Rate | 97.1 beats per minute |
| Placebo Nasal Spray | Change From Baseline in Heart Rate | Baseline Sitting Heart Rate | 92.7 beats per minute |
| Placebo Nasal Spray | Change From Baseline in Heart Rate | Post 4 -Week Sitting Heart Rate | 101.6 beats per minute |
p-value: >0.05Mixed Models Analysis
Secondary
Change From Baseline in Height.
Time frame: Baseline; Week 4
Population: Participants with available data are included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Height. | Baseline | 134 cm |
| Oxytocin Nasal Spray | Change From Baseline in Height. | Week 4 | 134 cm |
| Placebo Nasal Spray | Change From Baseline in Height. | Baseline | 129 cm |
| Placebo Nasal Spray | Change From Baseline in Height. | Week 4 | 129 cm |
p-value: >0.05Mixed Models Analysis
Secondary
Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.
Time frame: Baseline; Week 4
Population: Data not collected.
Secondary
Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.
Time frame: Up to 4 weeks
Population: Data were not collected for this outcome.
Secondary
Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.
Time frame: Up to 4 weeks
Population: Data were not not collected for this outcome.
Secondary
Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.
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
Population: Only analyzed after 4 weeks.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin Nasal Spray | 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 |
| Placebo Nasal Spray | Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment. | 5.79 units on a scale | Standard Error 2.78 |
p-value: 0.9757General Linear Model (GLM)
Secondary
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
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
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | 1.66 units on a scale | Standard Error 3.05 |
| Placebo Nasal Spray | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | 4.53 units on a scale | Standard Error 2.21 |
p-value: 0.3395General Linear Model (GLM)
Secondary
Change From Baseline in Plasma Oxytocin Levels During Treatment.
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
Population: Participants with available data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Plasma Oxytocin Levels During Treatment. | Baseline | 8.82 pg/mL | Standard Deviation 4.67 |
| Oxytocin Nasal Spray | Change From Baseline in Plasma Oxytocin Levels During Treatment. | Week 4 | 10.36 pg/mL | Standard Deviation 3.57 |
| Placebo Nasal Spray | Change From Baseline in Plasma Oxytocin Levels During Treatment. | Baseline | 8.66 pg/mL | Standard Deviation 3.85 |
| Placebo Nasal Spray | Change From Baseline in Plasma Oxytocin Levels During Treatment. | Week 4 | 8.40 pg/mL | Standard Deviation 3.57 |
Secondary
Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.
Time frame: Up to 4 weeks
Population: Data were not not collected for this outcome.
Secondary
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
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
Population: Participants with available data are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 19.6 |
| Oxytocin Nasal Spray | 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 |
| Placebo Nasal Spray | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Week 4 Communication Standard Scores | 78.29 units on a scale | Standard Deviation 19.12 |
| Placebo Nasal Spray | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Baseline Social Standard Score | 67.75 units on a scale | Standard Deviation 12.45 |
| Placebo Nasal Spray | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Baseline Communication Standard Scores | 71.80 units on a scale | Standard Deviation 17.85 |
| Placebo Nasal Spray | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Week 4 Social Standard Score | 70.92 units on a scale | Standard Deviation 14.23 |
Secondary
Change From Baseline in Weight
Time frame: Baseline; Week 4
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Oxytocin Nasal Spray | Change From Baseline in Weight | Baseline | 32.7 kilograms |
| Oxytocin Nasal Spray | Change From Baseline in Weight | Week 4 | 33.5 kilograms |
| Placebo Nasal Spray | Change From Baseline in Weight | Baseline | 28.0 kilograms |
| Placebo Nasal Spray | Change From Baseline in Weight | Week 4 | 28.4 kilograms |
p-value: >0.05Mixed Models Analysis
Secondary
Clinical Global Impression-Improvement (CGI-I) Score at Week 4
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
Population: Participants with available data are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Minimally Improved | 2 Participants |
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Minimally Worse | 0 Participants |
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Much Improved | 3 Participants |
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Much Worse | 0 Participants |
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | No Change | 9 Participants |
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Very Much Worse | 0 Participants |
| Oxytocin Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Very Much Improved | 0 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Very Much Worse | 0 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Very Much Improved | 0 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Much Improved | 3 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Minimally Improved | 5 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | No Change | 10 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Minimally Worse | 0 Participants |
| Placebo Nasal Spray | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Much Worse | 0 Participants |
Secondary
Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Cold Symptoms | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Fever | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Cough | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Headache | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Insomnia | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Excitement/Agitation | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Depressive Affect | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Labile Mood | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Silly Behavior | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | More Distractible | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Nasal Congestion | 3 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Epistaxis | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Sneezing | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Mouth Pain | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Intranasal Swelling | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Runny Nose | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Blinking Eyes | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Earache | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Nasal Discomfort | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Loose Stool | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Constipation | 1 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Stomach Discomfort | 0 participants |
| Oxytocin Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Skin Cut | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Epistaxis | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Cold Symptoms | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Earache | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Fever | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Sneezing | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Cough | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Constipation | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Headache | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Mouth Pain | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Insomnia | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Nasal Discomfort | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Excitement/Agitation | 2 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Intranasal Swelling | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Depressive Affect | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Skin Cut | 2 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Labile Mood | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Runny Nose | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Silly Behavior | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Loose Stool | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | More Distractible | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Blinking Eyes | 1 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Nasal Congestion | 0 participants |
| Placebo Nasal Spray | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Stomach Discomfort | 1 participants |
p-value: >0.05Fisher Exact
Secondary
Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
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
Population: Participants with available data are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Lethargy | 14.13 units on a scale | Standard Deviation 8.7 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Stereotypy | 5.69 units on a scale | Standard Deviation 6.2 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Oxytocin Nasal Spray | 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 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Week 4 Hyperactivity | 19.11 units on a scale | Standard Deviation 9.68 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Irritablity | 13.94 units on a scale | Standard Deviation 8.71 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Week 4 Stereotypy | 5.50 units on a scale | Standard Deviation 4.85 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Week 4 Irritability | 11.78 units on a scale | Standard Deviation 8.11 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Week 4 Inappropriate Speech | 4.17 units on a scale | Standard Deviation 3.31 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Lethargy | 11.7 units on a scale | Standard Deviation 8.34 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Hyperactivity | 23.28 units on a scale | Standard Deviation 10.74 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Week 4 Lethargy | 7.33 units on a scale | Standard Deviation 6.3 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Inappropriate Speech | 5.44 units on a scale | Standard Deviation 3.99 |
| Placebo Nasal Spray | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline Stereotypy | 5.61 units on a scale | Standard Deviation 4.55 |