Social Anxiety Disorder
Conditions
Keywords
propranolol, public speaking anxiety
Brief 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.
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.
Interventions
DRUGpropranolol
active treatment
DRUGPlacebo
inactive pill
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal Report of Confidence as a Speaker | 2 weeks | total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Avoidance Task | 2 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propranolol Propranolol 40 mg capsule, given once after fear activation procedure
propranolol: active treatment | 5 |
| Placebo Capsule Placebo capsule, given once after fear activation procedure
Placebo: inactive pill | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Propranolol | Placebo Capsule | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 5 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 1 |
| other Total, other adverse events | 0 / 5 | 0 / 1 |
| serious Total, serious adverse events | 0 / 5 | 0 / 1 |
Outcome results
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
Time frame: 2 weeks
Population: persons with fear of public speaking
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propranolol | Personal Report of Confidence as a Speaker | 6.6 change score on a scale |
| Placebo Capsule | Personal Report of Confidence as a Speaker | 6 change score on a scale |
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propranolol | Behavioral Avoidance Task | 4.2 steps |
| Placebo Capsule | Behavioral Avoidance Task | 4 steps |