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Recruiting
I'm InterestedTrial ID: NCT03204786
Intranasal Vasopressin Treatment in Children With Autism
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
Recruiting
I'm Interested
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Briana Hernandez
650-736-1235