NCT02871349

Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 7 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Propranolol	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.
DRUG	Placebo	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.
DEVICE	Magnetic Resonance Imaging (MRI)	An MRI will be performed on participants aged 15-24 years.

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2016-08-18
• Last updated: 2020-10-08

Locations

1 site across 1 country: United States