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NCT01962870 · ClinicalTrials.gov registry record · Phase 2
The Role of Vasopressin in the Social Deficits of Autism
A Phase 2 study of Autism Spectrum Disorders, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT01962870 is a Phase 2 study of Autism Spectrum Disorders that has completed, run by Stanford University. The registered enrollment target is 68 participants, below the 165-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01962870, a Phase 2 study of Autism Spectrum Disorders, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vasopressin
Study Locations (1)
California
- Stanford University School of Medicine; Psychiatry and Behavioral Sciences - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-05-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962870
The ClinicalTrials.gov registry entry for NCT01962870 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 165-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (59% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Autism Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01962870 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01962870 about?
NCT01962870 is a clinical study titled "The Role of Vasopressin in the Social Deficits of Autism". 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 p...
What is the current status of trial NCT01962870?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2013-12. Estimated completion is 2017-05-30.
What conditions does trial NCT01962870 study?
This clinical trial studies the following conditions: Autism Spectrum Disorders.
What interventions are being tested in trial NCT01962870?
The interventions under investigation include: Placebo (DRUG), Vasopressin (DRUG).
Who is sponsoring clinical trial NCT01962870?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01962870 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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