Social Anxiety DisorderPhase 4NCT02790736
Brief Intervention to Reduce Fear of Public Speaking
A Phase 4 study testing propranolol in people with Social Anxiety Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Anxiety Disorder
- 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 30 Oct 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age at the time of consent
- Principal Diagnosis of Social Anxiety Disorder, Performance only type
- Has clinically significant fear of public speaking
- Physically healthy
- If female, non-pregnant and not nursing
- Off all psychotropic drug for at least 4 weeks
- A level of understanding sufficient to provide written informed consent to all required study tests and procedures.
Who cannot join
- History of other serious psychiatric disorder
- Current Major Depressive Disorder
- Presence of developmental disorder or intellectual disability
- SAD patients with SAD not of the performance only type
- Women who are pregnant or nursing
- Current use of psychiatric medication
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- Current substance use disorder
- Persons planning to start another treatment during the study period.
- Any significant medical condition that might increase the risk or participation (e.g., seizure disorder, respiratory disorders [e.g., bronchial asthma], cardiovascular disease [e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and greater than first degree block ], low blood pressure [ < 90/60], diabetes, liver or kidney disorders)
- Use of medications that might negatively interact with propranolol (e.g., ACE inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel; phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute, 1051 Riverside Drive
New York, New York, 10032
About this study
The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.
Read the detailed description
Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance of public speaking. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear activation procedure. Primary outcome assessment will be self-reported fear of public speaking and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention.
- Conditions
- Social Anxiety Disorder
- Being tested
- propranolol, Placebo
- Keywords
- propranolol, public speaking anxiety
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Also called Innopran XL
active treatment
PlaceboDrug
Also called Placebo Oral Tablet
inactive pill
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Propranolol 40 mg capsule, given once after fear activation procedure Receives: Drug: propranolol |
| placebo capsule | Placebo comparator | Placebo capsule, given once after fear activation procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Report of Confidence as a Speaker
total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome
Measured: 2 weeks
Secondary outcomes (1)
Behavioral Avoidance Task
Up to 5 sequential public speaking challenges, specifically designed for each step to be of increasing difficulty for the individual. Each step is considered completed if subject agrees to try speaking, and speaks for 1 minute. Score is total number of completed steps (0-5) on this 5-step task, with 5 being best
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Why it stopped: COVID-19 restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklin Schneier, New York State Psychiatric Institute
- Investigators
- Franklin Schneier, MD, Study director, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790736
- Sponsor's protocol ID
- 7293 (SAD)
- Status last verified
- May 2023
- First submitted
- 26 May 2016
- Last updated
- 7 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Reduce Fear of Public Speaking
- ClinicalTrials.gov ID
- NCT02790736
- Acronym / sponsor ID
- 7293 (SAD)
- Conditions
- Social Anxiety Disorder
- Keywords
- propranolol, public speaking anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 restrictions
- Enrolment
- 6 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 5 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.
Detailed description
Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance of public speaking. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear activation procedure. Primary outcome assessment will be self-reported fear of public speaking and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: propranololPropranolol 40 mg capsule, given once after fear activation procedure |
| placebo capsule | Placebo comparator | Drug: PlaceboPlacebo capsule, given once after fear activation procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 years of age at the time of consent
- Principal Diagnosis of Social Anxiety Disorder, Performance only type
- Has clinically significant fear of public speaking
- Physically healthy
- If female, non-pregnant and not nursing
Key exclusion criteria (10 listed)
- History of other serious psychiatric disorder
- Current Major Depressive Disorder
- Presence of developmental disorder or intellectual disability
- SAD patients with SAD not of the performance only type
- Women who are pregnant or nursing
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: Innopran XLactive treatment | Drug | Propranolol |
| PlaceboAlso: Placebo Oral Tabletinactive pill | Drug | placebo capsule |
Primary outcome
Personal Report of Confidence as a Speaker
Time frame: 2 weeks
total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome
1 secondary outcome
Behavioral Avoidance Task
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Franklin Schneier, MD study director
NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propranolol in people with Social Anxiety Disorder, run by New York State Psychiatric Institute at 1 site in United States.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Personal Report of Confidence as a Speaker (time frame: 2 weeks). 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 7 Jun 2023.