AutismPhase 2/3NCT03204786

Intranasal Vasopressin Treatment in Children With Autism

A Phase 2/3 study testing Vasopressin (USP) Injectable Solution [Vasostrict] in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this clinical trial is to investigate the effectiveness of vasopressin nasal spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced naturally within the body and has been implicated in regulating social behaviors. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Autism, Autism Spectrum Disorder, ASD
What is being tested?: Vasopressin (USP) Injectable Solution [Vasostrict]
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 157 participants
Where: 1 siteUnited States
Study dates: 20 Feb 2018to 18 Mar 2024
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Medically healthy outpatients between 6 and 17 years of age;
Diagnostic and Statistical Manual 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2);
males and females;
intelligence quotient (IQ) of 40 and above;
rating of 4 or higher on the Social Communication domain of the Clinical Global Impressions Severity (CGI-S);
Social Responsiveness Scale-2 Total Score of 70 and above;

Show all 10Show fewer

care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis;
stable concomitant psychotropic medications or medications potentially affecting vasopressin for at least 4 weeks (with the exception of fluoxetine, 6 weeks);
no planned changes in psychosocial and biomedical interventions during the trial;
willingness to provide blood samples and ability to participate in key study procedures (i.e., diagnostic assessments and laboratory safety measurements).

Who cannot join

DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder;
regular nasal obstruction or nosebleeds;
unstable medical conditions such as migraine, asthma attacks, or seizures, and significant physical illness (e.g. serious liver disease, renal dysfunction, or cardiac pathology);
clinically significant abnormal electrocardiogram reading;
history of hypersensitivity to vasopressin, its analogs, or compounding preservatives (e.g., chlorobutanol);
evidence of a genetic mutation known to cause ASD or intellectual disability (e.g., Fragile X Syndrome); or metabolic, or infectious etiology for ASD on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis;

Show all 12Show fewer

significant hearing or vision impairments;
habitually drinks large volumes of water;
pregnant or sexually active females not using a reliable method of contraception;
current use of any medications known to interact with vasopressin including: 1) carbamazepine (i.e., Tegretol); chlorpropamide; clofibrate; urea; fludrocortisone; tricyclic antidepressants (all of which may potentiate the antidiuretic effect of vasopressin when used concurrently); 2) demeclocycline; norepinephrine; lithium; heparin; alcohol (all of which may decrease the antidiuretic effect of vasopressin when used concurrently); 3) ganglionic blocking agents including benzohexonium, chlorisondamine, pentamine (all of which may produce a marked increase in sensitivity to the pressor effects of vasopressin);
previous participation in a vasopressin clinical trial or current use of vasopressin;
current use of desmopressin (DDAVP) or oxytocin.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305-5719

Other trials in United States

About this study

Conditions: Autism, Autism Spectrum Disorder, ASD
Being tested: Vasopressin (USP) Injectable Solution [Vasostrict], Placebo
Keywords: Autism Spectrum Disorder (ASD), Autism
Medical subject headings: Autistic Disorder, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vasopressin (USP) Injectable Solution [Vasostrict]Drug
Nasal Spray
PlaceboDrug
Placebo Nasal Spray

Study groups in NCT03204786
Study group	Role	What they receive
Vasopressin-Vasopressin	Experimental	8 weeks of vasopressin nasal spray (16 international units twice daily) Receives: Drug: Vasopressin (USP) Injectable Solution [Vasostrict]
Placebo-Vasopressin	Experimental	4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily) Receives: Drug: Vasopressin (USP) Injectable Solution [Vasostrict]; Drug: Placebo
Placebo-Placebo	Placebo comparator	8 weeks of placebo nasal spray; followed by a 4 week open-label extension of vasopressin nasal spray (16 international units twice daily) Receives: Drug: Vasopressin (USP) Injectable Solution [Vasostrict]; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment.
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).
Measured: baseline, 4-week, 8-week

Secondary outcomes (28)

Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment.
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.
Measured: baseline; 4-week; 8-week
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment.
Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions.
Measured: baseline; 4-week; 8-week
Change From Baseline on the Facial Emotion Recognition Test During Treatment.
Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities.
Measured: baseline; 4-week; 8-week
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors.
Measured: baseline; 4-week; 8-week
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
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.
Measured: baseline; 4-week; 8-week
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment.
Change from baseline on blood clinical labs (Chloride) during treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (CO2) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment.
Measured: Up to 12 weeks
Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment.
Measured: Up to 12 weeks
Change From Baseline on Vital Signs (Pulse) During Treatment.
Measured: Up to 12 weeks
Change From Baseline on Height During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Weight During Treatment.
Measured: baseline to 4-week, 8-week, and 12-week
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment.
The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment.
Measured: Up to 12 weeks
Number of Participants Reporting Aggression Using the Overt Aggression Scale (OAS) During Treatment.
The scale evaluates the child participant's aggression. The number of children who exhibited aggression as reported by the parent is reported.
Measured: baseline, 4-weeks, 8-weeks
Adverse Event Severity
Adverse events collated according to intensity for each pre-allocated treatment group.
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201818 Mar 2024

First posted2 Jul 2017
Study start20 Feb 2018
Primary completion18 Mar 2024
Study completion18 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AutismStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03204786
Sponsor's protocol ID: IRB-39972
Other IDs: 1R01HD091972
Status last verified: May 2026
First submitted: 28 Jun 2017
Last updated: 4 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: National Database for Autism Research (NDAR) Submission per NIH requirements

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autism trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intranasal Vasopressin Treatment in Children With Autism
ClinicalTrials.gov ID: NCT03204786
Acronym / sponsor ID: IRB-39972
Conditions: Autism, Autism Spectrum Disorder, ASD
Keywords: Autism Spectrum Disorder (ASD), Autism
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 20 Feb 2018 (actual)
Primary completion: 18 Mar 2024 (actual)
Study completion: 18 Mar 2024 (actual)
First posted: 2 Jul 2017 (actual)
Results: Posted 19 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Vasopressin-Vasopressin	Experimental	Drug: Vasopressin (USP) Injectable Solution [Vasostrict]8 weeks of vasopressin nasal spray (16 international units twice daily)
Placebo-Vasopressin	Experimental	Drug: Vasopressin (USP) Injectable Solution [Vasostrict], Drug: Placebo4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)
Placebo-Placebo	Placebo comparator	Drug: Vasopressin (USP) Injectable Solution [Vasostrict], Drug: Placebo8 weeks of placebo nasal spray; followed by a 4 week open-label extension of vasopressin nasal spray (16 international units twice daily)

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Medically healthy outpatients between 6 and 17 years of age;
Diagnostic and Statistical Manual 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2);
males and females;
intelligence quotient (IQ) of 40 and above;
rating of 4 or higher on the Social Communication domain of the Clinical Global Impressions Severity (CGI-S);

Key exclusion criteria (12 listed)

DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder;
regular nasal obstruction or nosebleeds;
unstable medical conditions such as migraine, asthma attacks, or seizures, and significant physical illness (e.g. serious liver disease, renal dysfunction, or cardiac pathology);
clinically significant abnormal electrocardiogram reading;
history of hypersensitivity to vasopressin, its analogs, or compounding preservatives (e.g., chlorobutanol);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vasopressin (USP) Injectable Solution [Vasostrict]Nasal Spray	Drug	Placebo-Placebo, Placebo-Vasopressin, Vasopressin-Vasopressin
PlaceboPlacebo Nasal Spray	Drug	Placebo-Placebo, Placebo-Vasopressin

Primary outcome

Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment.
Time frame: 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).

28 secondary outcomes

Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment.
Time frame: baseline; 4-week; 8-week
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment.
Time frame: baseline; 4-week; 8-week
Change From Baseline on the Facial Emotion Recognition Test During Treatment.
Time frame: baseline; 4-week; 8-week
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Time frame: baseline; 4-week; 8-week
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
Time frame: baseline; 4-week; 8-week
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (CO2) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment.
Time frame: Up to 12 weeks
Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment.
Time frame: Up to 12 weeks
Change From Baseline on Vital Signs (Pulse) During Treatment.
Time frame: Up to 12 weeks
Change From Baseline on Height During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on Weight During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment.
Time frame: Up to 12 weeks
Number of Participants Reporting Aggression Using the Overt Aggression Scale (OAS) During Treatment.
Time frame: baseline, 4-weeks, 8-weeks
Adverse Event Severity
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 19 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vasopressin-Vasopressin	23	22
Placebo-Vasopressin	46	41
Placebo-Placebo	39	39

Primary outcome: Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment.

Time frame: baseline, 4-week, 8-week. Least squares mean (Standard Error). Unit: T-score

Measure	Vasopressin-Vasopressin n = 22	Placebo-Vasopressin n = 41	Placebo-Placebo n = 39
Total score - baseline	81.3690 (2.1052)	79.6795 (1.5448)	82.2281 (1.5650)
Total score - change from baseline at 4-week	-5.6779 (1.6830)	-4.5448 (1.2298)	-6.4832 (1.2695)
Total score - 4-week	75.0000 (2.1052)	74.7821 (1.5448)	74.8816 (1.5650)
Total score - change from week 4 at week 8	-3.4420 (1.7758)	-5.3854 (1.2964)	-1.0443 (1.3267)
SCI score - baseline	81.2500 (2.0892)	79.3333 (1.5330)	81.5987 (1.5531)
SCI score - change from baseline at 4-week	-5.6451 (1.6475)	-4.6366 (1.2024)	-6.3462 (1.2385)
SCI score - 4-week	74.9405 (2.0892)	74.3718 (1.5330)	74.5263 (1.5531)
SCI score - change from week 4 at week 8	-2.8205 (1.7326)	-5.1550 (1.2689)	-0.9782 (1.2962)

Population analysed: Participants with available data at the respective time point

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: UP to 12 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vasopressin-Vasopressin Group - Treatment Period 1	0 of 22 (0%)	12 of 22 (54.5%)	0 of 22
Placebo-Vasopressin Group - Treatment Period 1	0 of 42 (0%)	31 of 42 (73.8%)	0 of 42
Placebo-Placebo Group - Treatment Period 1	0 of 39 (0%)	29 of 39 (74.4%)	0 of 39
Vasopressin-Vasopressin Group - Treatment Period 2	0 of 21 (0%)	15 of 21 (71.4%)	0 of 21
Placebo-Vasopressin Group - Treatment Period 2	0 of 38 (0%)	24 of 38 (63.2%)	0 of 38
Placebo-Placebo Group - Treatment Period 2	0 of 39 (0%)	26 of 39 (66.7%)	0 of 39
Open-label Vasopressin	0 of 32 (0%)	20 of 32 (62.5%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. National Database for Autism Research (NDAR) Submission per NIH requirements

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Y. Hardan, M.D. principal investigator

Stanford University

Karen J. Parker, Ph.D. principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vasopressin (USP) Injectable Solution [Vasostrict] in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. (time frame: baseline, 4-week, 8-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.