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This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.
The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VQW-765 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VQW-765 | Drug | oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Units of Distress Scale (SUDS) | Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Units of Distress Scale (SUDS) | Subjective Units of Distress Scale (SUDS) during anticipation phase, scored from 0-100 with a higher score indicating higher distress. | 1 day |
| State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals, Inc. | Contact | 202-734-3400 | clinicaltrials@vandapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Recruiting | Phoenix | Arizona | 85012 | United States | |
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| Drug |
oral capsule |
|
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S), scored from 20 to 80 with higher scores indicating higher anxiety level.
| 1 day |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Assessment of safety and tolerability of VQW-765, as measured by spontaneous reporting of adverse events (AEs) | 2 weeks |
| Vanda Investigational Site |
| Recruiting |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Vanda Investigational Site | Recruiting | Encino | California | 91316 | United States |
| Vanda Investigational Site | Recruiting | Mission Viejo | California | 92691 | United States |
| Vanda Investigational Site | Recruiting | San Diego | California | 92123 | United States |
| Vanda Investigational Site | Recruiting | San Jose | California | 95124 | United States |
| Vanda Investigational Site | Recruiting | Walnut Creek | California | 94596 | United States |
| Vanda Investigational Site | Recruiting | Denver | Colorado | 80209 | United States |
| Vanda Investigational Site | Recruiting | Jacksonville | Florida | 32256 | United States |
| Vanda Investigational Site | Recruiting | Miami | Florida | 33125 | United States |
| Vanda Investigational Site | Recruiting | Orlando | Florida | 32801 | United States |
| Vanda Investigational Site | Recruiting | Tampa | Florida | 33629 | United States |
| Vanda Investigational Site | Recruiting | Atlanta | Georgia | 30329 | United States |
| Vanda Investigational Site | Recruiting | Suwanee | Georgia | 30024 | United States |
| Vanda Investigational Site | Recruiting | New Orleans | Louisiana | 70115 | United States |
| Vanda Investigational Site | Recruiting | Pikesville | Maryland | 21208 | United States |
| Vanda Investigational Site | Recruiting | Rockville | Maryland | 20852 | United States |
| Vanda Investigational Site | Terminated | Towson | Maryland | 21204 | United States |
| Vanda Investigational Site | Recruiting | Saint Charles | Missouri | 63304 | United States |
| Vanda Investigational Site | Recruiting | St Louis | Missouri | 63182 | United States |
| Vanda Investigational Site | Recruiting | Las Vegas | Nevada | 89102 | United States |
| Vanda Investigational Site | Recruiting | Princeton | New Jersey | 08540 | United States |
| Vanda Investigational Site | Active, not recruiting | Albuquerque | New Mexico | 87109 | United States |
| Vanda Investigational Site | Recruiting | New York | New York | 10016 | United States |
| Vanda Investigational Site | Recruiting | New York | New York | 10036 | United States |
| Vanda Investigational Site | Active, not recruiting | Charlotte | North Carolina | 28210 | United States |
| Vanda Investigational Site | Active, not recruiting | Wilmington | North Carolina | 28403 | United States |
| Vanda Investigational Site | Active, not recruiting | Moosic | Pennsylvania | 18507 | United States |
| Vanda Investigational Site | Recruiting | Houston | Texas | 77081 | United States |
| Vanda Investigational Site | Recruiting | Wichita Falls | Texas | 76309 | United States |
| Vanda Investigational Site | Active, not recruiting | Orem | Utah | 84097 | United States |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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