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COVID-19 restrictions
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Experimental | Propranolol 40 mg capsule, given once after fear activation procedure |
|
| placebo capsule | Placebo Comparator | Placebo capsule, given once after fear activation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propranolol | Drug | active treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Schneier, MD | NYSPI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute, 1051 Riverside Drive | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propranolol | Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment |
| FG001 | Placebo Capsule | Placebo capsule, given once after fear activation procedure Placebo: inactive pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propranolol | Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment |
| BG001 | Placebo Capsule | Placebo capsule, given once after fear activation procedure Placebo: inactive pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | persons with fear of public speaking | Posted | Mean | Full Range | change score on a scale | 2 weeks |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propranolol | Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment |
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Early termination of this pilot study leading to small numbers of subjects evaluated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franklin Schneier MD | NY State Psychiatric Institute | 6467748041 | fschneier@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 9, 2018 | Jul 12, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| C477592 | propranolol CR |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo | Drug | inactive pill |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Posted | Mean | Full Range | steps | 2 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo Capsule | Placebo capsule, given once after fear activation procedure Placebo: inactive pill | 0 | 1 | 0 | 1 | 0 | 1 |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |