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

NCT02414451 | Withdrawn

• 1 other identifier: 200089
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism

Keywords

Propranolol

Outcome Measures

Primary Outcomes (2)

• Change in General Social Outcome Measure (GSOM)

  The GSOM is a brief evaluation tool that measures a participant's level of social functioning and how it changes with intervention. There GSOM includes 4 different tasks: conversational reciprocity, ability to recognize facial expressions, social problem solving, affect demonstration, and emotional perspective taking. The experimenter administers each component of the GSOM to the participant and then scores their responses according to a pre-determined scoring rubric. Each component is scored on a 1-5 or 0 - 2 scale, with higher total scores indicating better social functioning. A video camera will be used to record the participant's behavior during GSOM administration for the purposes of having two independent raters score the tasks after the study session is complete. The video camera will be turned off for the remainder of the study session. A camera will also be used during the affect demonstration task of the GSOM.

  Week 1, Week 4, Week 8, Week 12, Week 15, Week 19

• Change in Social Responsiveness Scale (SRS)

  This 65-item, parent-report measure asks questions about a participants' social awareness, social information processing, capacity for reciprocal social responses, social anxiety or avoidance, and characteristic autistic preoccupations or traits.

  Week 1, Week 4, Week 8, Week 12, Week 15, Week 19

Secondary Outcomes (9)

• Change in Anagrams task

  Week 1, Week 4, Week 8, Week 12, Week 15, Week 19

• Change in Verbal fluency for categories task

  Week 1, Week 4, Week 8, Week 12, Week 15, Week 19

• Change in Spence Children's Anxiety Scale (SCAS)

  Week 1, Week 4, Week 8, Week 12, Week 15, Week 19

• Vertical attention task

  Week 1

• Change in Clinical Global Impression of Change (CGIC) scale

  Week 4, Week 8, Week 12, Week 15, Week 19

Study Arms (2)

Propranolol arm

EXPERIMENTAL

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

Drug: Propranolol

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Propranolol 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

Also known as: Inderal

Propranolol arm

Placebo 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

Placebo arm

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Conditions

Autistic Disorder

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• David Q Beversdorf, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Radiology, Neurology, and Psychology

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: April 10, 2015
• Study Start: September 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10