Columbia, Missouri 65211


Purpose:

The purpose of this study is to explore the effects of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled pilot trial.


Study summary:

The investigators' specific aim is to examine the effects of serial doses of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in children 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 pupillary light reflex and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that propranolol will augment the effects of behavioral therapy on social functioning and language abilities. The investigators have demonstrated benefits of propranolol on social functioning and language in previous single-dose studies in adults and adolescents with autism. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.


Criteria:

Inclusion Criteria: - Diagnosis of autism spectrum disorder (ASD), defined in this study by the DSM-V criteria plus Autism Diagnostic Observation Schedule (ADOS) criteria for Autism. - Aged 3-8 - Participants must also be enrolled in an early behavioral intervention program at the Thompson Center or another institution in Missouri for the duration of the study. Exclusion Criteria: - Non-autism learning disability (e.g. dyslexia) - Major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder) - Other neurological diagnosis - Major head trauma - Any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, known hypersensitivity/adverse reaction to beta-blockers, potentially interacting drugs, underweight < 15 kg) - Any of the following exclusionary criteria related to the use of electrocardiogram (history of rash from adhesives) - Any of the following exclusionary criteria related to the pupillary reflex measurement (uncorrectable visual acuity impairment). - Participants with a heart rate of less than 60 or a systolic blood pressure of less than 75 at the outset of the study will be excluded.


NCT ID:

NCT02428205


Primary Contact:

Principal Investigator
David Q Beversdorf, MD
University of Missouri-Columbia

David Q Beversdorf, MD
Phone: 573-882-6081
Email: beversdorfd@health.missouri.edu


Backup Contact:

Email: mutcnair@mail.missouri.edu
Neetu Nair, BTech
Phone: 573-882-0131


Location Contact:

Columbia, Missouri 65211
United States

David Q Beversdorf, MD
Phone: 573-882-6081
Email: beversdorfd@health.missouri.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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