Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response

Autism Spectrum Disorder Clinical Trial

Official title:

Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871349
• Other study ID #: 2005213
• Status: Completed
• Phase: Early Phase 1
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: October 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Propranolol
Propanolol will be given on a titration schedule in which participants will begin with small doses (single capsules) of the drug and increase to a larger dosage (divided over 3 capsules) over the course of three weeks. Participants aged 15-24 years will undergo an MRI.
• Placebo
Placebo will be given in the form preferred by the participant and on the same schedule as the propanolol regime. Participants aged 15-24 years will undergo an MRI.

Device:
• Magnetic Resonance Imaging (MRI)
An MRI will be performed on participants aged 15-24 years.

Locations

Country	Name	City	State
United States	Thompson Center for Autism & Neurodevelopmental Disorders	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Companion Animal Bonding Scale		Day 1, 6 weeks, 12 weeks
Other	Change in Sympathetic Tone & Anxiety Measurements	Pupillary light reflex, heart rate, heart rate variability, skin conductance, and blood pressure	Day 1, 12 weeks
Other	Changes in salivary cortisol		Day 1, 6 weeks, 12 weeks
Other	Changes in Sensory Over-Responsivity questionnaire		Day 1, 6 weeks, 12 weeks
Primary	Change in General Social Outcomes Measure (GSOM) Assessment		Day 1, 6 weeks, 12 weeks
Secondary	Change in Social Responsiveness Scale (SRS-2)		Day 1, 6 weeks, 12 weeks
Secondary	Change in score on Anagrams test	For those aged 15-24 only	Day 1, 6 weeks, 12 weeks
Secondary	Change in Semantic fluency test results	For those aged 15-24 only	Day 1, 6 weeks, 12 weeks
Secondary	Change Clinical Global Impression surveys		Day 1, 6 weeks, 12 weeks
Secondary	Change in Autism Impact Measure (AIM)		Day 1, 6 weeks, 12 weeks
Secondary	Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment		Day 1, 6 weeks, 12 weeks
Secondary	Change in Vineland Adaptive Behavior Scales (VABS-2) assessment		Day 1, 6 weeks, 12 weeks
Secondary	Change in score on Aberrant Behavior Checklist (ABC)		Day 1, 6 weeks, 12 weeks
Secondary	Change in gastrointestinal symptomology	Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults	Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks