Trial · NCT03204786
Intranasal Vasopressin Treatment in Children With Autism
NCT03204786, Phase 2, Phase 3, Completed, Stanford University; results first posted 2025-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intranasal Vasopressin Treatment in Children With Autism. Trials, record NCT03204786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03204786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Vasopressin Treatment in Children With Autism
- NCT number
- NCT03204786
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 157 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Autism, Autism Spectrum Disorder, ASD
- Interventions
- Vasopressin (USP) Injectable Solution [Vasostrict], Placebo
- First posted
- 2017-07-02
- Last updated
- 2026-06-04
- Results first posted
- 2025-09-19
Source ClinicalTrials.gov
Registered outcomes48
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, Second Edition (SRS-2) Total Scores During Treatment. | baseline, 4-week, 8-week | Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit). |
| Secondary | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | baseline; 4-week; 8-week | Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores. * Higher scores on the CGI-S mean greater social and communication deficits (range: 1 to 7). * Lower scores on the CGI-I correspond to greater improvement in the areas assessed in the CGI-S, and higher scores correspond to worsening (range: 1 to 7). There is no baseline score for the CGI-I, it represents the clinician's subjective assessment of change. |
| Secondary | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | baseline; 4-week; 8-week | Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. |
| Secondary | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | baseline; 4-week; 8-week | Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities. |
| Secondary | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | baseline; 4-week; 8-week | Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors. |
| Secondary | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | baseline; 4-week; 8-week | Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. |
| Secondary | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | baseline to 4-week, 8-week, and 12-week | |
| Secondary | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | |
| Secondary | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | |
| Secondary | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | baseline to 4-week, 8-week, and 12-week |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
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, Second Edition (SRS-2) Total Scores During Treatment. | baseline, 4-week, 8-week | Participants with available data at the respective time point | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | baseline; 4-week; 8-week | Participants with data at the respective time point | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | baseline; 4-week; 8-week | Participants with data at the respective time point | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | baseline; 4-week; 8-week | Participants with data at the respective time point | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | baseline; 4-week; 8-week | Participants with data at the respective time point | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | baseline; 4-week; 8-week | Participants with data at the respective time point | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | baseline to 4-week, 8-week, and 12-week | Participants with available data at the respective time point | milliseconds | MEAN |
| SECONDARY | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | Participants with available data at the respective time point | milliseconds | MEAN |
| SECONDARY | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | Participants with available data at the respective time point | milliseconds | MEAN |
| SECONDARY | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | Participants with available data at the respective time point | milliseconds | MEAN |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group503
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, Second Edition (SRS-2) Total Scores During Treatment. | Vasopressin-Vasopressin | Total score - baseline | 81.3690 | Standard Error 2.1052 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Placebo-Vasopressin | Total score - baseline | 79.6795 | Standard Error 1.5448 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Placebo-Placebo | Total score - baseline | 82.2281 | Standard Error 1.5650 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Vasopressin-Vasopressin | Total score - change from baseline at 4-week | -5.6779 | Standard Error 1.6830 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Placebo-Vasopressin | Total score - change from baseline at 4-week | -4.5448 | Standard Error 1.2298 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Placebo-Placebo | Total score - change from baseline at 4-week | -6.4832 | Standard Error 1.2695 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Vasopressin-Vasopressin | Total score - 4-week | 75.0000 | Standard Error 2.1052 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Placebo-Vasopressin | Total score - 4-week | 74.7821 | Standard Error 1.5448 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Placebo-Placebo | Total score - 4-week | 74.8816 | Standard Error 1.5650 | T-score |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Vasopressin-Vasopressin | Total score - change from week 4 at week 8 | -3.4420 | Standard Error 1.7758 | T-score |
1 to 10 of 503Source ClinicalTrials.gov
See all 503 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (4 Weeks) | STARTED | Vasopressin-Vasopressin | 23 | |
| Treatment Period 1 (4 Weeks) | STARTED | Placebo-Vasopressin | 46 | |
| Treatment Period 1 (4 Weeks) | STARTED | Placebo-Placebo | 39 | |
| Treatment Period 1 (4 Weeks) | Received Intervention | Vasopressin-Vasopressin | 23 | |
| Treatment Period 1 (4 Weeks) | Received Intervention | Placebo-Vasopressin | 44 | |
| Treatment Period 1 (4 Weeks) | Received Intervention | Placebo-Placebo | 39 | |
| Treatment Period 1 (4 Weeks) | COMPLETED | Vasopressin-Vasopressin | 22 | |
| Treatment Period 1 (4 Weeks) | COMPLETED | Placebo-Vasopressin | 41 | |
| Treatment Period 1 (4 Weeks) | COMPLETED | Placebo-Placebo | 39 | |
| Treatment Period 1 (4 Weeks) | NOT COMPLETED | Vasopressin-Vasopressin | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events462
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 | Dizziness | Cardiac disorders | Vasopressin-Vasopressin Group - Treatment Period 1 | 0 | 22 | |
| other | Dizziness | Cardiac disorders | Placebo-Vasopressin Group - Treatment Period 1 | 1 | 42 | |
| other | Dizziness | Cardiac disorders | Placebo-Placebo Group - Treatment Period 1 | 1 | 39 | |
| other | Dizziness | Cardiac disorders | Vasopressin-Vasopressin Group - Treatment Period 2 | 0 | 21 | |
| other | Dizziness | Cardiac disorders | Placebo-Vasopressin Group - Treatment Period 2 | 0 | 38 | |
| other | Dizziness | Cardiac disorders | Placebo-Placebo Group - Treatment Period 2 | 0 | 39 | |
| other | Dizziness | Cardiac disorders | Open-label Vasopressin | 1 | 32 | |
| other | Earache | Ear and labyrinth disorders | Vasopressin-Vasopressin Group - Treatment Period 1 | 0 | 22 | |
| other | Earache | Ear and labyrinth disorders | Placebo-Vasopressin Group - Treatment Period 1 | 1 | 42 | |
| other | Earache | Ear and labyrinth disorders | Placebo-Placebo Group - Treatment Period 1 | 0 | 39 |
1 to 10 of 462Source ClinicalTrials.gov
See all 462 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vasopressin-Vasopressin Group - Treatment Period 1 | 0 | 22 |
| Total, all-cause mortality | Placebo-Vasopressin Group - Treatment Period 1 | 0 | 42 |
| Total, all-cause mortality | Placebo-Placebo Group - Treatment Period 1 | 0 | 39 |
| Total, all-cause mortality | Vasopressin-Vasopressin Group - Treatment Period 2 | 0 | 21 |
| Total, all-cause mortality | Placebo-Vasopressin Group - Treatment Period 2 | 0 | 38 |
| Total, all-cause mortality | Placebo-Placebo Group - Treatment Period 2 | 0 | 39 |
| Total, all-cause mortality | Open-label Vasopressin | 0 | 32 |
| Total, other adverse events | Vasopressin-Vasopressin Group - Treatment Period 1 | 12 | 22 |
| Total, other adverse events | Placebo-Vasopressin Group - Treatment Period 1 | 31 | 42 |
| Total, other adverse events | Placebo-Placebo Group - Treatment Period 1 | 29 | 39 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD091972 | Intranasal vasopressin treatment in children with autism | PARKER, KAREN J.; HARDAN, ANTONIO | STANFORD UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Emoji Emotion Recognition | Secondary outcome |
Source ConductCognition
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.
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