Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response

NCT ID: NCT02414451

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-09-30

Brief Summary

The purpose of this study is to explore the effects of propranolol on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.

Detailed Description

The investigators' specific aim 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 and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, as the investigators have demonstrated in previous single-dose studies. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Conditions

Autism

Study Design

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

Study Groups

Propranolol arm

Propranolol will be administered via oral capsule(s) daily for a period of 10 weeks, involving gradual titration up from 40mg to 100mg and subsequent tapering off of the drug. The titration/tapering schedule will be as follows:

Week 1: 40 mg propranolol (1 capsule, nightly) Week 2: 80 mg propranolol (2 40mg capsules, morning & night) Weeks 3 - 8: 100 mg propranolol (3 capsules, 40 mg/morning, 20mg/afternoon, & 40mg/night) Week 9: 60 mg propranolol (2 capsules, 40 mg/morning & 20mg/night) Week 10: 20 mg propranolol (1 capsule, nightly) Week 11: no capsules

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Week 1: 40 mg propranolol (1 capsule, nightly) Week 2: 80 mg propranolol (2 40mg capsules, morning \& night) Weeks 3 - 8: 100 mg propranolol (3 capsules, 40 mg/morning, 20mg/afternoon, \& 40mg/night) Week 9: 60 mg propranolol (2 capsules, 40 mg/morning \& 20mg/night) Week 10: 20 mg propranolol (1 capsule, nightly) Week 11: no capsules

Placebo arm

Placebo will be administered via lactose-filled oral capsule(s) daily for a period of 10 weeks. The schedule of placebo administration will be as follows:

Week 1: 1 capsule, nightly Week 2: 2 capsules, morning & night Weeks 3 - 8: 3 capsules, morning, afternoon, & night Week 9: 2 capsules, morning & night Week 10: 1 capsule, nightly Week 11: no capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered via lactose-filled oral capsule(s) daily for a period of 10 weeks. The schedule of placebo administration will be as follows:

Week 1: 1 capsule, nightly Week 2: 2 capsules, morning & night Weeks 3 - 8: 3 capsules, morning, afternoon, & night Week 9: 2 capsules, morning & night Week 10: 1 capsule, nightly Week 11: no capsules

Interventions

Propranolol

Week 1: 40 mg propranolol (1 capsule, nightly) Week 2: 80 mg propranolol (2 40mg capsules, morning \& night) Weeks 3 - 8: 100 mg propranolol (3 capsules, 40 mg/morning, 20mg/afternoon, \& 40mg/night) Week 9: 60 mg propranolol (2 capsules, 40 mg/morning \& 20mg/night) Week 10: 20 mg propranolol (1 capsule, nightly) Week 11: no capsules

Intervention Type: DRUG

Placebo

Placebo will be administered via lactose-filled oral capsule(s) daily for a period of 10 weeks. The schedule of placebo administration will be as follows:

Week 1: 1 capsule, nightly Week 2: 2 capsules, morning & night Weeks 3 - 8: 3 capsules, morning, afternoon, & night Week 9: 2 capsules, morning & night Week 10: 1 capsule, nightly Week 11: no capsules

Intervention Type: DRUG

Other Intervention Names

Inderal

Eligibility Criteria

Inclusion Criteria

• For participants with autism: High-functioning, native-English speaking subjects with ASD aged 15-30. High-functioning ASD is defined in this study by the DSM-V criteria plus Autism Diagnostic Interview-Revised (ADI-R) criteria for Autism, and Wechsler Abbreviated Scales of Intelligence (WASI) full scale IQ of at least 85.

Exclusion Criteria

• For participants with autism: Non-autism learning disability (e.g. dyslexia),
• major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder),
• other neurological diagnosis,
• major head trauma,
• any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, pregnancy, known hypersensitivity/adverse reaction to beta-blockers),
• any of the following exclusionary criteria related to placebo (severe allergy to lactose),
• any of the following exclusionary criteria related to the psychophysiological measurements (history of rash from adhesives).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Beversdorf

Associate Professor, Radiology, Neurology, and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Q Beversdorf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Other Identifiers

200089

Identifier Type: -

Identifier Source: org_study_id