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

NCT ID: NCT02871349

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-08-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Propanolol and 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.

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

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.

Magnetic Resonance Imaging (MRI)

Intervention Type: DEVICE

An MRI will be performed on participants aged 15-24 years.

Placebo and MRI

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Magnetic Resonance Imaging (MRI)

Intervention Type: DEVICE

An MRI will be performed on participants aged 15-24 years.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Magnetic Resonance Imaging (MRI)

An MRI will be performed on participants aged 15-24 years.

Intervention Type: DEVICE

Other Intervention Names

Inderal; Hemangeol; Innopran

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Beversdorf

Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Q Beversdorf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2005213

Identifier Type: -

Identifier Source: org_study_id