Status:
COMPLETED
Propranolol for Challenging Behaviors in Autism
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
New Jersey Governor's Council for Medical Research and Treatment of Autism
New York State Institute for Basic Research
Conditions:
Autism Spectrum Disorder
Developmental Disability
Eligibility:
All Genders
12-30 years
Phase:
PHASE2
Brief Summary
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 tw...
Detailed Description
This is a randomized, double blind, placebo controlled crossover study. A complete cardiac exam will be conducted by the pediatric cardiology team at the Robert Wood Johnson Medical School. All partic...
Eligibility Criteria
Inclusion
- Males and females between the ages of 12-30 years and is a resident in the state of New Jersey.
- Diagnosis of autism conducted by a clinician with confirmation using the Autism Diagnostic Observation Schedule (ADOS) or the Social Communication Questionnaire (SCQ).
- At least one of the following challenging behaviors.
- Self-injurious behaviors (e.g., hitting one's self, head banging or banging of other body parts causing some degree of tissue damage);
- Physical aggression towards others (e.g., hitting, kicking, pushing, or throwing objects at others);
- Disruptive behaviors including property destruction during anger episodes, excessive screaming which interferes with functioning; and
- The challenging behaviors are generally (but not necessarily exclusively) associated with a congruent affect (i.e. anger or rage when aggressing) as determined by the study psychiatrist.
- Pharmacologic treatment with at least two psychotropic including one antipsychotic medication has yielded inadequate outcome (partial improvement on one or more medications is acceptable for the study).
- Clinical Global Impression Severity scale score of 6 or 7.
- Aberrant Behavior Checklist--Community Irritability scale score at or above 18.
- Medical and cardiac clearance.
Exclusion
- Asthma or any history of asthma or any disorder involving bronchoconstriction.
- Cardiac Diseases in which the use of propranolol at high doses would be contraindicated.
- Uncontrolled Seizure disorder (participant had a seizure within the past year and/or changes in seizure medication in the previous six months).
- Diabetes or a history of ketoacidosis.
- Any other medical disorder or medication which would contraindicate the use of propranolol.
- History of allergy or adverse reaction to propranolol.
- Pregnancy.
- Medication exclusions include clonidine/guanfacine / digoxin or other medications affecting blood pressure.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04047355
Start Date
February 11 2021
End Date
September 30 2023
Last Update
June 4 2025
Active Locations (1)
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1
Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901