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Vasopressin Nasal Spray for Autism
Phase 2 & 3
Waitlist Available
Led By Karen J. Parker, Ph.D.
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medically healthy outpatients between 6 and 17 years of age
IQ of 40 and above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-week, 4-week; 6-week, 8-week
Awards & highlights
Study Summary
This trial is testing whether a vasopressin nasal spray can help improve social functioning in people with autism.
Who is the study for?
This trial is for medically healthy children aged 6-17 with Autism Spectrum Disorder, as confirmed by specific diagnostic tools. Participants must have a certain level of social impairment and an IQ over 40. They should be on stable medications, if any, and not planning to change treatments during the study. Exclusions include previous vasopressin trials, certain mental health diagnoses, unstable medical conditions, pregnancy without contraception use, and regular nasal issues.Check my eligibility
What is being tested?
The trial tests whether a hormone called vasopressin can improve social functioning in autistic children when given as a nasal spray compared to a placebo (a substance with no active drug). Vasopressin naturally occurs in the body and influences social behavior. Children will randomly receive either the hormone or placebo to assess its effectiveness.See study design
What are the potential side effects?
Potential side effects from vasopressin may include water retention leading to an imbalance of salts in the blood (hyponatremia), headache, abdominal cramps, nausea or vomiting. There might also be local reactions at the site of administration like irritation or nosebleeds.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 17 years old and generally healthy.
Select...
My IQ is 40 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-week, 4-week; 6-week, 8-week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-week, 4-week; 6-week, 8-week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in parent rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores during treatment.
Secondary outcome measures
Baseline vasopressin concentration predicting primary and secondary behavioral outcome measures.
Change from baseline in Clinical Global Impression (CGI) scores during treatment.
Change from baseline in Overt Aggression Scale (OAS) during treatment.
+25 moreOther outcome measures
Change from baseline in Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) score during treatment.
Change from baseline in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Social Skills and Relationships Domain during treatment.
Change from baseline in parent rated Child's Sleep Habits Questionnaire (CSHQ) Score during treatment.
+15 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Vasopressin-VasopressinExperimental Treatment1 Intervention
8 weeks of vasopressin nasal spray (16 international units twice daily)
Group II: Placebo-VasopressinExperimental Treatment2 Interventions
4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)
Group III: Placebo-PlaceboPlacebo Group2 Interventions
8 weeks of placebo nasal spray; followed by a 4 week open-label extension of vasopressin nasal spray (16 international units twice daily)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vasopressin (USP) Injectable Solution [Vasostrict]
2018
Completed Phase 3
~110
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,942 Total Patients Enrolled
33 Trials studying Autism Spectrum Disorder
3,989 Patients Enrolled for Autism Spectrum Disorder
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,633 Total Patients Enrolled
34 Trials studying Autism Spectrum Disorder
9,694 Patients Enrolled for Autism Spectrum Disorder
Karen J. Parker, Ph.D.Principal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have major hearing or vision problems.I am not pregnant and use reliable birth control.I am currently taking medication that interacts with vasopressin.I am either male or female.You have significant difficulties in social communication as rated by a clinical assessment.I have been in a vasopressin study or am currently using vasopressin.I have been diagnosed with schizophrenia, schizoaffective disorder, or another psychotic disorder.I have a genetic mutation linked to autism or intellectual disability.I am between 6 and 17 years old and generally healthy.My IQ is 40 or higher.You need to have an IQ score of 40 or higher.I do not have uncontrolled medical conditions like severe migraines, asthma, or seizures.I often have a blocked nose or nosebleeds.My mental health or vasopressin-affecting medications have been stable for the last 4 weeks.I am currently taking desmopressin or oxytocin.
Research Study Groups:
This trial has the following groups:- Group 1: Vasopressin-Vasopressin
- Group 2: Placebo-Vasopressin
- Group 3: Placebo-Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the condition being treated in this trial currently able to enroll?
"This clinical trial, which is currently recruiting participants, was first posted on February 20, 2018 and was most recently edited on September 11, 2022."
Answered by AI
Do elderly patients meet the requirements for this experiment?
"This particular clinical trial is only for children aged 6 to 17. Out of the 304 total clinical trials, 253 of them are for patients under the age of 18."
Answered by AI
Am I eligible to take part in this research study?
"This trial is seeking around 100 participants who have a diagnosis of autism spectrum disorder and are aged between 6-17."
Answered by AI
Who else is applying?
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Son has asd and heard vasopressin maybe help his socialize.
PatientReceived no prior treatments
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