Intranasal Vasopressin Treatment in Children With Autism

Not Recruiting

Trial ID: NCT03204786


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. It has been proposed that administration of the hormone may also help improve social functioning in individuals with autism.

Official Title

Intranasal Vasopressin Treatment in Children With Autism

Stanford Investigator(s)

Antonio Hardan, M.D.
Antonio Hardan, M.D.

Professor of Psychiatry and Behavioral Sciences


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.


drug: Vasopressin (USP) Injectable Solution [Vasostrict]

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Briana Hernandez