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

Early Phase 1CompletedNCT02871349

University of Missouri-Columbia69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

PropranololDRUG

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.

PlaceboDRUG

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.

Magnetic Resonance Imaging (MRI)DEVICE

An MRI will be performed on participants aged 15-24 years.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 24 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Autism Spectrum Disorder diagnosis * intelligence quotient (IQ) \>= 85 (if aged 15-24), \>= 75 (if aged 7-14) * Native English speaker * Parent or caregiver must older than 18 years and be a native English speaker Exclusion Criteria: * Taking Alpha 2 agonists * Non-autism learning disorder * Other major psychiatric disorders * Other neurological disorders * Major head trauma * Reaction to adhesives * Diabetes * Reactive airway disease * Thyroid disease * Bradyarrhythmias * Unexplained syncope * Pregnancy * Possible interacting drugs * Underweight (\<20kg if aged 7-14 years) * Factors affecting ability to have an MRI (if aged 15-24 years)

Locations (1)

Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, United States