Clinical trial NCT02414451: Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response
Official title: Trial of Propranolol in Adults and Adolescents With Autism Spectrum Disorder (ASD) and Predictors of Response
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism
Keywords: Propranolol
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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).

Primary outcomes:
measure: Change in General Social Outcome Measure (GSOM)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Social Responsiveness Scale (SRS)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Secondary outcomes:
measure: Change in Anagrams task
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Verbal fluency for categories task
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Spence Children's Anxiety Scale (SCAS)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Vertical attention task
timeFrame: Week 1
measure: Change in Clinical Global Impression of Change (CGIC) scale
timeFrame: Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Autism Impact Measure (AIM)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Vineland Adaptive Behavior Scales-II (VABS)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Aberrant Behavior Checklist (ABC)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
measure: Change in Clinical Global Impression of Severity (CGIS) scale
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: David Q Beversdorf, MD
role: PRINCIPAL_INVESTIGATOR
References: