The Role of Vasopressin in the Social Deficits of Autism

Status Completed

Clinical Trial Summary

Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder. Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone. There are currently no effective medicines available to treat social problems in individuals with autism. Neuropeptides, such as vasopressin and oxytocin, are molecules used by neurons in the brain to communicate with one another. Vasopressin is closely related to oxytocin, which is currently being tested as a treatment for autism, and has been shown to enhance social functioning in animals. Animal studies have shown that when the proper functioning of vasopressin is experimentally altered, animals develop a variety of social deficits, including impaired memory for peers and a reduced interest in social interaction. Researchers found that when vasopressin was administered to mice with a genetically induced form of autism, their social functioning improved. Vasopressin is already approved by the Food and Drug Administration for use in humans, and has proved to be a successful treatment for some common pediatric conditions, including bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and memory in people who do not have autism. The researchers will test the effects of vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study will last four weeks for each participant. Participants will receive either vasopressin or a placebo nasal spray. At the end of this phase of the study, those who received the placebo will have the option of participating in a four-week trial during which they will be given vasopressin. Stanford is the only site for the study. Participants do not need to live locally but will need to come to the Stanford University Department of Psychiatry and Behavioral Sciences for study visits.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01962870
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Phase 2
Start date	December 2013
Completion date	May 30, 2017

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02625116` - ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders
Not yet recruiting	`NCT06381856` - Improving Participation of Autistic Children and Adolescents in the Habilitation Process
Recruiting	`NCT02280746` - Gluten for Autism Spectrum Disorders	N/A
Completed	`NCT01945957` - Brain Imaging of Intranasal Oxytocin Treatment in Autism	Phase 1
Completed	`NCT01661855` - A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD	Phase 2
Completed	`NCT01691066` - Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder	N/A
Completed	`NCT01592747` - Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine	Phase 2
Completed	`NCT01780090` - Handheld Technology for Speech Development in Students With Autism	N/A
Completed	`NCT01694667` - Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder	Phase 2
Active, not recruiting	`NCT01417026` - Intranasal Oxytocin and Learning in Autism	Phase 2
Enrolling by invitation	`NCT01364818` - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment	N/A
Completed	`NCT01695200` - Omega-3 Fatty Acids in Autism Spectrum Disorders	Phase 4
Completed	`NCT02300597` - Internet-based Support for Young People With ADHD and Autism - a Controlled Study	N/A
Not yet recruiting	`NCT00695812` - The Development of Younger Siblings of Children With Autism Now at 10 Years of Age	N/A
Completed	`NCT01675414` - Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)	N/A
Recruiting	`NCT05910502` - Project AFECT (Autism Family Empowerment Coaching and Training Program)	N/A
Completed	`NCT02081027` - Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders	Early Phase 1
Completed	`NCT02797379` - The Development of a Psychoeducational Tool to Manage Anxiety in People With Autism Spectrum Disorders	N/A
Terminated	`NCT01730079` - Near Infrared Spectroscopy in Children With Autism and ADHD
Completed	`NCT01603225` - Transcranial Direct Current Stimulation and Autism

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.