NCT02414451

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

Trial of Propranolol in Adults and Adolescents With Autism Spectrum Disorder (ASD) and Predictors of Response

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-04-10
• Last updated: 2016-10-04