Skip to main content
OpenTrials
Completed

NCT Number: NCT02871349

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propranolol

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.

Other names: Inderal, Hemangeol, Innopran

Placebo

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)

Device

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

Primary outcomes

  1. Change in General Social Outcomes Measure (GSOM) Assessment

    Time frame: Day 1, 6 weeks, 12 weeks

Secondary outcomes

  1. Change in Social Responsiveness Scale (SRS-2)

    Time frame: Day 1, 6 weeks, 12 weeks

  2. Change in score on Anagrams test

    Time frame: Day 1, 6 weeks, 12 weeks

    For those aged 15-24 only

  3. Change in Semantic fluency test results

    Time frame: Day 1, 6 weeks, 12 weeks

    For those aged 15-24 only

  4. Change Clinical Global Impression surveys

    Time frame: Day 1, 6 weeks, 12 weeks

  5. Change in Autism Impact Measure (AIM)

    Time frame: Day 1, 6 weeks, 12 weeks

  6. Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment

    Time frame: Day 1, 6 weeks, 12 weeks

  7. Change in Vineland Adaptive Behavior Scales (VABS-2) assessment

    Time frame: Day 1, 6 weeks, 12 weeks

  8. Change in score on Aberrant Behavior Checklist (ABC)

    Time frame: Day 1, 6 weeks, 12 weeks

  9. Change in gastrointestinal symptomology

    Time frame: 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

Other outcomes

  1. Change in Companion Animal Bonding Scale

    Time frame: Day 1, 6 weeks, 12 weeks

  2. Change in Sympathetic Tone & Anxiety Measurements

    Time frame: Day 1, 12 weeks

    Pupillary light reflex, heart rate, heart rate variability, skin conductance, and blood pressure

  3. Changes in salivary cortisol

    Time frame: Day 1, 6 weeks, 12 weeks

  4. Changes in Sensory Over-Responsivity questionnaire

    Time frame: Day 1, 6 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 18, 2016
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.