Intranasal Vasopressin Treatment in Children With Autism

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.