Severe challenging behaviors such as aggression and self-injury can cause significant
morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders
(ASD). There are only two medications (Risperdal and Abilify) rigorously studied and
FDA-approved for the treatment of irritability in individuals with ASD. These medications are
not always successful and have many short and long-term side effects. Well-designed studies
demonstrating efficacy and safety of alternative medication treatment choices are needed.
There is preliminary evidence that high-dose propranolol can be effective in individuals with
ASD who display severe aggression and have not responded to antipsychotics or mood
stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical
application. Well-designed clinical trials demonstrating the efficacy and safety of high dose
propranolol will have significant effects on clinical practice and improve the physical and
behavioral quality of life for an underserved subset of individuals with ASD.
This study will pilot the safety and efficacy of high dose propranolol. The investigators
will randomly assign participants to either propranolol or to placebo later crossing each
participant over to the other group. As propranolol can cause changes in blood pressure and
heart function, each participant will complete initial comprehensive testing to monitor
cardiac safety throughout the study. The investigators will be utilizing telemedicine and
computer based telemetry to minimize the burden of office visits on the individual and
family.
Phase:
Phase 2
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborators:
New Jersey Governor's Council for Medical Research and Treatment of Autism New Jersey Governor’s Council for Medical Research and Treatment of Autism New York State Institute for Basic Research