Clinical trial NCT02871349: Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
Official title: Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Autism Spectrum Disorder
Keywords: Autism
ASD
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-08-18
Enrollment: 69
Sex: ALL
Minimum age (years): 7
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in General Social Outcomes Measure (GSOM) Assessment
timeFrame: Day 1, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in Social Responsiveness Scale (SRS-2)
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in score on Anagrams test
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in Semantic fluency test results
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change Clinical Global Impression surveys
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in Autism Impact Measure (AIM)
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in Vineland Adaptive Behavior Scales (VABS-2) assessment
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in score on Aberrant Behavior Checklist (ABC)
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in gastrointestinal symptomology
timeFrame: Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks
Other outcomes:
measure: Change in Companion Animal Bonding Scale
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Change in Sympathetic Tone & Anxiety Measurements
timeFrame: Day 1, 12 weeks
measure: Changes in salivary cortisol
timeFrame: Day 1, 6 weeks, 12 weeks
measure: Changes in Sensory Over-Responsivity questionnaire
timeFrame: Day 1, 6 weeks, 12 weeks
Locations:
city: Columbia
country: United States
facility: Thompson Center for Autism & Neurodevelopmental Disorders
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: David Q Beversdorf, MD
role: PRINCIPAL_INVESTIGATOR
References: