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

University of Missouri (MU)

Status and phase: Completed; Early Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Drug: Propranolol; Drug: Placebo; Device: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02871349

2005213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 7 to 24 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups, including a placebo group

Propanolol and MRI

Experimental group

Description:

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.

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Drug: Propranolol

Placebo and MRI

Placebo Comparator group

Description:

Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug.

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Drug: Placebo