AutismNCT02414451
Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response
A study testing Propranolol in people with Autism, run by University of Missouri-Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Autism
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Trial of Propranolol in Adults and Adolescents With Autism Spectrum Disorder (ASD) and Predictors of Response
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.
Read the 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
- Being tested
- Propranolol, Placebo
- Keywords
- Propranolol
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Inderal
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Secondary outcomes (9)
Change in Anagrams task
To assess verbal problem solving, participants will be given a set of 20 anagram s (scrambled words, where letters are rearranged to form a word: e.g., IRCKB → BRICK). A maximum of 120 seconds will be allowed for each anagram. Number solved and solution latency (with failed anagrams recorded as 120 seconds) will be recorded.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Verbal fluency for categories task
To assess verbal and semantic fluency, participants will be asked to generate as many words as possible within one minute each from three different categories (e.g. animals, things to wear, vegetables). Total number of distinct words (not including proper nouns) will be recorded for each session.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Spence Children's Anxiety Scale (SCAS)
To assess anxiety, the SCAS will be completed by the participants. This self-report measure yields a total score in addition to six subscales (separation anxiety, social phobia, obsessive compulsive, panic/agoraphobia, physical injury fears, and generalized anxiety).
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Vertical attention task
At the initial study visit only, a vertical spatial attention task will be administered to assess whether individuals with ASD display a vertical attention bias. A 4'x 3' board will be hung in the exam room in the landscape orientation, and the experimenter will present a total of 72 lines on the board for the participant to bisect or quadrisect (i.e., "place a mark in the middle of the line" or "place a mark that is one quarter or 25% from the top or bottom of the line") with a pen at one of three spatial positions (above eye level, eye level, below eye level).
Measured: Week 1
Change in Clinical Global Impression of Change (CGIC) scale
To assess overall changes in the participant's ASD-related clinical symptoms, the CGIC will be administered. The CGIC consists of a 7-point subjective scale assessing change from baseline. On this scale, scores of 1, 2, and 3 represent marked, moderate, and mild improvement, respectively. A score of 4 represents no change. Scores of 5, 6, and 7 represent mild, moderate, and marked worsening, respectively. CGIC scores from both the parent/caregiver and the blinded PI (licensed physician) will be utilized.
Measured: Week 4, Week 8, Week 12, Week 15, Week 19
Change in Autism Impact Measure (AIM)
The AIM will be administered to assess the frequency and impact of a participant's ASD-related symptoms. A parent/caregiver is asked a series of 41 questions regarding the frequency and the impact, or interference resulting from, a series of autism-associated behaviors. Overall impact and frequency scores, as well as subscale scores, will be obtained from this measure.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Vineland Adaptive Behavior Scales-II (VABS)
To assess overall adaptive functioning, the VABS will be administered in the form of a structured interview with the parent/caregiver. The VABS is a well validated assessment used for the full range of our subjects' ages and yields standard scores in Communication, Daily Living Skills, Socialization, and Motor Skills. VABS scores for Communication, Daily Living Skills, and Socialization will be monitored in this study.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Aberrant Behavior Checklist (ABC)
To assess overall behavioral disturbances, a parent/caregiver of the participants will complete ABC. This 58-item questionnaire is a well validated, reliable, and widely used assessment tool for interventions for a range of cognitive disorders.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Clinical Global Impression of Severity (CGIS) scale
To assess overall severity of a participant's ASD-related clinical symptoms, the CGIS will be administered. The CGIS consists of a 7-point subjective scale assessing symptom severity. On this scale, scores of 1, 2, and 3 represent normal, some presence of symptoms, and mild behavior, respectively. A score of 4 represents moderate behavior. Scores of 5, 6, and 7 represent marked, severe, and among the most severe behavior, respectively. CGIS scores from both the parent/caregiver and the blinded PI (licensed physician) will be utilized.
Measured: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startSep 2016
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: No need for a pilot study. New study will be opened.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Beversdorf, University of Missouri-Columbia
- Investigators
- David Q Beversdorf, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414451
- Sponsor's protocol ID
- 200089
- Status last verified
- Oct 2016
- First submitted
- 20 Mar 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Propranolol in Adults and Adolescents With Autism Spectrum Disorder (ASD) and Predictors of Response
- ClinicalTrials.gov ID
- NCT02414451
- Acronym / sponsor ID
- 200089
- Conditions
- Autism
- Keywords
- Propranolol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No need for a pilot study. New study will be opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol arm | Experimental | Drug: PropranololPropranolol 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 |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAlso: InderalWeek 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 arm |
| PlaceboPlacebo 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 arm |
Primary outcome
Change in General Social Outcome Measure (GSOM)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
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.
Change in Social Responsiveness Scale (SRS)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
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.
9 secondary outcomes
Change in Anagrams task
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Verbal fluency for categories task
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Spence Children's Anxiety Scale (SCAS)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Vertical attention task
Time frame: Week 1
Change in Clinical Global Impression of Change (CGIC) scale
Time frame: Week 4, Week 8, Week 12, Week 15, Week 19
Change in Autism Impact Measure (AIM)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Vineland Adaptive Behavior Scales-II (VABS)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Aberrant Behavior Checklist (ABC)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Change in Clinical Global Impression of Severity (CGIS) scale
Time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Q Beversdorf, MD principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol in people with Autism, run by University of Missouri-Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General Social Outcome Measure (GSOM) (time frame: Week 1, Week 4, Week 8, Week 12, Week 15, Week 19). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.