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NCT01093768 · ClinicalTrials.gov registry record · Phase 1
Brain Imaging Study of Adults With Autism Spectrum Disorders
A Phase 1 study of Autism Spectrum Disorders, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01093768: Completed Phase 1 study of Autism Spectrum Disorders, sponsored by National Institute of Mental Health (NIMH).
NCT01093768 is a Phase 1 study of Autism Spectrum Disorders that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 38 participants, below the 166-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01093768, a Phase 1 study of Autism Spectrum Disorders, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study investigates the effects of oxytocin and vasopressin on brain activity in adults with Autism Spectrum Disorders using functional magnetic resonance imaging (fMRI). Background: \- Oxytocin and vasopressin are two hormones produced in the brain. Both hormones can influence activity in brain regions such as the amygdala that are involved in social and emotional processing. There is evidence suggesting that oxytocin and vasopressin may be implicated in autism spectrum disorders (ASD). Objectives: -Here, we use functional magnetic resonance imaging (fMRI) to assess the effects of oxytocin and vasopressin on brain activity in adult healthy volunteers and adults with ASD. Eligibility: \- Right-handed individuals between 18 and 40 years of age who either have been diagnosed with autism, Asperger s disorder, or Pervasive Developmental Disorder- Not Otherwise Specified (PDD-NOS), or are healthy volunteers. Design: * This study requires 3 outpatient visits to the NIH Clinical Center in addition to a screening visit. Each visit will last about 2.5 hours. Participants may not smoke cigarettes or drink alcohol or caffeinated beverages for 12 hours before each visit. * During each visit, participants will receive a nasal spray that contains one of the following: oxytocin, vasopressin, or placebo. Participants will receive a different spray at each visit. * After using the nasal spray, participants will have an MRI scan of the brain while performing tasks with social and emotional stimuli. * After the MRI scan, participants will complete questionnaires about mood and reaction to the tasks, and will remain in the clinic until the effects of the study medication have worn off. * Participants will be contacted 1 day after each MRI scan for follow-up purposes.
Conditions Studied
Interventions
- DRUG Vasopressin
- DRUG Oxytocin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-02-19 |
| Est. Completion | 2013-04-11 |
| Phase | Phase 1 |
What the finished NCT01093768 record still lists
NCT01093768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 166-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Autism Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Vasopressin is the first listed.
NCT01093768 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01093768 about?
NCT01093768 is a clinical study titled "Brain Imaging Study of Adults With Autism Spectrum Disorders". This research study investigates the effects of oxytocin and vasopressin on brain activity in adults with Autism Spectrum Disorders using functional magnetic resonance imaging (fMRI). Background: \- Oxytocin and vasopressin are two hormones produced in the brain. Both hormones can influence activi...
What is the current status of trial NCT01093768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-02-19. Estimated completion is 2013-04-11.
What conditions does trial NCT01093768 study?
This clinical trial studies the following conditions: Autism Spectrum Disorders.
What interventions are being tested in trial NCT01093768?
The interventions under investigation include: Vasopressin (DRUG), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT01093768?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01093768 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01093768's enrollment target sits among peer trials
38 12th of 20 higher than 9 of 20 other Autism Spectrum Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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