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Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response

Information source: University of Missouri-Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism

Intervention: Propranolol (Drug); Placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Missouri-Columbia

Official(s) and/or principal investigator(s):
David Q Beversdorf, MD, Principal Investigator, Affiliation: University of Missouri-Columbia

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

Summary

The purpose of this study is to explore the effects of propranolol on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.

Clinical Details

Official title: Trial of Propranolol in Adults and Adolescents With Autism Spectrum Disorder (ASD) and Predictors of Response

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Change in General Social Outcome Measure (GSOM)

Change in Social Responsiveness Scale (SRS)

Secondary outcome:

Change in Anagrams task

Change in Verbal fluency for categories task

Change in Spence Children's Anxiety Scale (SCAS)

Vertical attention task

Change in Clinical Global Impression of Change (CGIC) scale

Change in Autism Impact Measure (AIM)

Change in Vineland Adaptive Behavior Scales-II (VABS)

Change in Aberrant Behavior Checklist (ABC)

Change in Clinical Global Impression of Severity (CGIS) scale

Detailed description: The investigators' specific aim 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 and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, as the investigators have demonstrated in previous single-dose studies. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Eligibility

Minimum age: 15 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- For participants with autism: High-functioning, native-English speaking subjects with

ASD aged 15-30. High-functioning ASD is defined in this study by the DSM-V criteria plus Autism Diagnostic Interview-Revised (ADI-R) criteria for Autism, and Wechsler Abbreviated Scales of Intelligence (WASI) full scale IQ of at least 85. Exclusion Criteria:

- For participants with autism: 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, pregnancy, known hypersensitivity/adverse reaction to beta-blockers),

- any of the following exclusionary criteria related to placebo (severe allergy to

lactose),

- any of the following exclusionary criteria related to the psychophysiological

measurements (history of rash from adhesives).

Locations and Contacts

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

Additional Information

Starting date: September 2015
Last updated: April 9, 2015

Page last updated: August 23, 2015

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