Trial · NCT01624194
Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
NCT01624194, Phase 2, Completed, Stanford University; results first posted 2018-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intranasal Oxytocin Treatment for Social Deficits in Children With Autism. Trials, record NCT01624194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01624194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
- NCT number
- NCT01624194
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Autism
- Interventions
- Oxytocin nasal spray, Placebo
- First posted
- 2012-06-20
- Last updated
- 2019-07-15
- Results first posted
- 2018-06-06
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | Change From Baseline in Height. | Baseline; Week 4 | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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) |
| Secondary | 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. |
| Secondary | Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment. | Up to 4 weeks | |
| Secondary | Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment. | Baseline; Week 4 | |
| Secondary | Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment. | Up to 4 weeks |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | Baseline; Week 4 | Participants who completed the protocol are included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Baseline through Week 4 | participants | NUMBER | |
| SECONDARY | Change From Baseline in Height. | Baseline; Week 4 | Participants with available data are included in the analysis. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Baseline to Week 4 | Participants with available data are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline; Week 4 | Participants with available data are included. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Baseline; Week 4 | Participants who completed the protocol are included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Baseline; Week 4 | Participants with available data are included. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment. | Up to 4 weeks | Data were not collected for this outcome. | ||
| SECONDARY | Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment. | Baseline; Week 4 | Data not collected. | ||
| SECONDARY | Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment. | Up to 4 weeks | Data were not not collected for this outcome. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | Oxytocin Nasal Spray | 9.73 | Standard Error 2.64 | units on a scale | |
| Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | Placebo Nasal Spray | 3.18 | Standard Error 2.18 | units on a scale | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Oxytocin Nasal Spray | Cold Symptoms | 0 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Placebo Nasal Spray | Cold Symptoms | 1 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Oxytocin Nasal Spray | Fever | 0 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Placebo Nasal Spray | Fever | 1 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Oxytocin Nasal Spray | Cough | 1 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Placebo Nasal Spray | Cough | 0 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Oxytocin Nasal Spray | Headache | 1 | participants | |
| Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Placebo Nasal Spray | Headache | 0 | participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxytocin Nasal Spray | 16 | |
| Overall Study | STARTED | Placebo Nasal Spray | 18 | |
| Overall Study | COMPLETED | Oxytocin Nasal Spray | 14 | |
| Overall Study | COMPLETED | Placebo Nasal Spray | 18 | |
| Overall Study | NOT COMPLETED | Oxytocin Nasal Spray | 2 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Spray | 0 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cold Symptoms | General disorders | Oxytocin Nasal Spray | 0 | 14 | |
| other | Cold Symptoms | General disorders | Placebo Nasal Spray | 1 | 18 | |
| other | Fever | General disorders | Oxytocin Nasal Spray | 0 | 14 | |
| other | Fever | General disorders | Placebo Nasal Spray | 1 | 18 | |
| other | Cough | General disorders | Oxytocin Nasal Spray | 1 | 14 | |
| other | Cough | General disorders | Placebo Nasal Spray | 0 | 18 | |
| other | Headache | Nervous system disorders | Oxytocin Nasal Spray | 1 | 14 | |
| other | Headache | Nervous system disorders | Placebo Nasal Spray | 0 | 18 | |
| other | Insomnia | Psychiatric disorders | Oxytocin Nasal Spray | 1 | 14 | |
| other | Insomnia | Psychiatric disorders | Placebo Nasal Spray | 1 | 18 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxytocin Nasal Spray | 0 | 14 |
| Total, all-cause mortality | Placebo Nasal Spray | 0 | 18 |
| Total, other adverse events | Oxytocin Nasal Spray | 11 | 14 |
| Total, other adverse events | Placebo Nasal Spray | 12 | 18 |
| Total, serious adverse events | Oxytocin Nasal Spray | 0 | 14 |
| Total, serious adverse events | Placebo Nasal Spray | 0 | 18 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oxytocin Nasal Spray vs Placebo Nasal Spray: deaths from any cause | Trial comparisons |
| Oxytocin Nasal Spray vs Placebo Nasal Spray: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01624194
GET https://conductscience.org/api/trials/v1/NCT01624194/results?page=2