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 taskChange 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
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