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Could a nasal spray boost social skills in kids with autism?

NCT ID NCT03204786

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a nasal spray containing vasopressin, a natural hormone, can improve social functioning in children with autism. 157 children aged 6 to 17 took part. Researchers measured changes in social responsiveness and overall symptoms over 8 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vasopressin nasal spray
What this could lead to
If it works, this could offer a new way to improve social communication in children with autism.
What could go wrong
This is an early-stage trial with mixed results. The hormone may not work for everyone, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

157 people

The number who actually took part.

Started

Feb 2018

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * 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). Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Stanford University

    Stanford, California, 94305-5719, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.