Thompson Center for Autism & Neurodevelopmental Disorders
Columbia, Missouri, 65211, United States
NCT Number: NCT02871349
The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure
This research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.
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Notify Me7 year–24 year
All sexes
Interventional
Early Phase 1
Columbia, Missouri, 65211, United States
The specific aim of this study is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance, heart rate variability (HRV), and the pupillary light reflex (PLR), and whether anxiety can predict treatment response. The hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, and that those with the greatest degree of autonomic dysregulation, or the lowest functional connectivity, will demonstrate the greatest benefit from the drug.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propanolol will be given on a titration schedule in which participants will begin with small doses (single capsules) of the drug and increase to a larger dosage (divided over 3 capsules) over the course of three weeks. Participants aged 15-24 years will undergo an MRI.
Other names: Inderal, Hemangeol, Innopran
Placebo will be given in the form preferred by the participant and on the same schedule as the propanolol regime. Participants aged 15-24 years will undergo an MRI.
An MRI will be performed on participants aged 15-24 years.
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
For those aged 15-24 only
Time frame: Day 1, 6 weeks, 12 weeks
For those aged 15-24 only
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks
Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 12 weeks
Pupillary light reflex, heart rate, heart rate variability, skin conductance, and blood pressure
Time frame: Day 1, 6 weeks, 12 weeks
Time frame: Day 1, 6 weeks, 12 weeks
University of Missouri-Columbia
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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