Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
- Conditions
- Autism Spectrum Disorder
- Interventions
- Registration Number
- NCT02871349
- Lead Sponsor
- University of Missouri-Columbia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo and MRI Placebo Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug. Propanolol and MRI Magnetic Resonance Imaging (MRI) Participants will receive propranolol via oral capsule, crushed tablet, or liquid daily. The drug dosage will be titrated slowly to ensure the drug is tolerated well. Those aged 15-24 will have an MRI before starting drug. Placebo and MRI Magnetic Resonance Imaging (MRI) Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug. Propanolol and MRI Propranolol Participants will receive propranolol via oral capsule, crushed tablet, or liquid daily. The drug dosage will be titrated slowly to ensure the drug is tolerated well. Those aged 15-24 will have an MRI before starting drug.
- Primary Outcome Measures
Name Time Method Change in General Social Outcomes Measure (GSOM) Assessment Day 1, 6 weeks, 12 weeks
- Secondary Outcome Measures
Name Time Method Change in score on Anagrams test Day 1, 6 weeks, 12 weeks For those aged 15-24 only
Change in Social Responsiveness Scale (SRS-2) Day 1, 6 weeks, 12 weeks Change in Semantic fluency test results Day 1, 6 weeks, 12 weeks For those aged 15-24 only
Change Clinical Global Impression surveys Day 1, 6 weeks, 12 weeks Change in Autism Impact Measure (AIM) Day 1, 6 weeks, 12 weeks Change in score on Aberrant Behavior Checklist (ABC) Day 1, 6 weeks, 12 weeks Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment Day 1, 6 weeks, 12 weeks Change in Vineland Adaptive Behavior Scales (VABS-2) assessment Day 1, 6 weeks, 12 weeks Change in gastrointestinal symptomology Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults
Trial Locations
- Locations (1)
Thompson Center for Autism & Neurodevelopmental Disorders
🇺🇸Columbia, Missouri, United States