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Intranasal Vasopressin Treatment in Children With Autism

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ClinicalTrials.gov Identifier: NCT03204786
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Brief Summary:
This purposed 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.

Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Disorder ASD Drug: Vasopressin (USP) Injectable Solution [Vasostrict] Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intranasal Vasopressin Treatment in Children With Autism
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Vasopressin

Arm Intervention/treatment
Experimental: Vasopressin-Vasopressin
8 weeks of vasopressin nasal spray (16 international units twice daily)
Drug: Vasopressin (USP) Injectable Solution [Vasostrict]
Nasal Spray

Experimental: Placebo-Vasopressin
4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)
Drug: Vasopressin (USP) Injectable Solution [Vasostrict]
Nasal Spray

Drug: Placebo
Placebo Nasal Spray

Placebo Comparator: Placebo-Placebo
8 weeks of placebo nasal spray; followed by a 4 week open-label extension of vasopressin nasal spray (16 international units twice daily)
Drug: Vasopressin (USP) Injectable Solution [Vasostrict]
Nasal Spray

Drug: Placebo
Placebo Nasal Spray




Primary Outcome Measures :
  1. Change from baseline in parent rated Social Responsiveness Scale, Second Edition (SRS-2) total scores during treatment. [ Time Frame: 4-week; 8-week ]

Secondary Outcome Measures :
  1. Change from baseline in Clinical Global Impression (CGI) scores during treatment. [ Time Frame: 4-week; 8-week ]
  2. Change from baseline in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Social Skills and Relationships Domain during treatment. [ Time Frame: 4-week; 8-week ]
  3. Change from baseline in parent rated Repetitive Behavior Scale Revised (RBS-R) scores during treatment. [ Time Frame: 4-week; 8-week ]
  4. Change from baseline in parent rated Spence Children's Anxiety Scale (SCAS) during treatment. [ Time Frame: 4-week; 8-week ]
  5. Change from baseline in parent rated Pediatric Quality of Life (PedsQL) inventory scores during treatment. [ Time Frame: 4-week; 8-week ]
  6. Change from baseline in Overt Aggression Scale (OAS) during treatment. [ Time Frame: 2-week, 4-week; 6-week, 8-week ]
  7. Change from baseline on Eye Gaze Assessment (eye tracking) during treatment. [ Time Frame: 4-week; 8-week ]
  8. Change from baseline on Reading the Mind in the Eyes Test (RMET) during treatment. [ Time Frame: 4-week; 8-week ]
  9. Change from baseline on the Developmental Neuropsychological Assessment, Second Edition (NEPSY-II) Theory of Mind Test during treatment. [ Time Frame: 4-week; 8-week ]
  10. Change from baseline the Diagnostic Analysis of Nonverbal Accuracy, Second Edition (DANVA-2) Child Voices Prosody Test during treatment. [ Time Frame: 4-week; 8-week ]
  11. Change from baseline on the Facial Emotion Recognition Test during treatment. [ Time Frame: 4-week; 8-week ]
  12. Change from baseline on electrocardiogram (EKG) during treatment. [ Time Frame: 2-week, 4-week; 6-week, 8-week ]
  13. Change from baseline on blood biomarkers vasopressin levels during treatment. [ Time Frame: 4-week; 8-week ]
  14. Change from baseline on clinical labs during treatment. [ Time Frame: 2-week, 4-week; 6-week, 8-week ]
  15. Change from baseline on blood pressure during treatment. [ Time Frame: 2-week, 4-week; 6-week, 8-week ]
  16. Change from baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) during treatment. [ Time Frame: 2-week, 4-week; 6-week, 8-week ]
  17. Change from baseline in parent rated Stanford Social Motivation Scale (SSMS) total scores during treatment. [ Time Frame: 4-week; 8-week ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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);
  • males and females;
  • intelligence quotient (IQ) of 50 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204786


Contacts
Contact: Kathy Leung (650) 736-1235 kleung19@stanford.edu
Contact: Robin Libove (650) 736-1235 rlibove@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305-5719
Contact: Kathy Leung    650-736-1235    kleung19@stanford.edu   
Contact: Robin Libove    (650) 736-1235    rlibove@stanford.edu   
Sponsors and Collaborators
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Antonio Y. Hardan, M.D. Stanford University
Principal Investigator: Karen J. Parker, Ph.D. Stanford University

Responsible Party: Antonio Hardan, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03204786     History of Changes
Other Study ID Numbers: IRB-39972
1R01HD091972 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: National Database for Autism Research (NDAR) Submission per NIH requirements

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Hardan, Stanford University:
Autism Spectrum Disorder (ASD)
Autism

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Mental Disorders
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs