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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 male and female participants with performance anxiety.
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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) | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Global Impression of Change (CGI-C) scale at visit 2 | 1 Day | |
| Patient Global Impression of Change (PGI-C) scale at visit 2 | 1 Day | |
| Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Tempe | Arizona | 85281 | United States | ||
| Vanda Investigational Site |
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| Drug |
oral capsule |
|
| 1 Day |
| Beverly Hills |
| California |
| 90212 |
| United States |
| Vanda Investigational Site | Garden Grove | California | 92845 | United States |
| Vanda Investigational Site | San Jose | California | 95124 | United States |
| Vanda Investigational Site | Torrance | California | 90502 | United States |
| Vanda Investigational Site | Orlando | Florida | 32816 | United States |
| Vanda Investigational Site | Boston | Massachusetts | 02114 | United States |
| Vanda Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Vanda Investigational Site | Berlin | New Jersey | 08009 | United States |
| Vanda Investigational Site | New York | New York | 10016 | United States |
| Vanda Investigational Site | Staten Island | New York | 10312 | United States |
| Vanda Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Vanda Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Vanda Investigational Site | Houston | Texas | 77074 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2024 | Apr 16, 2024 | 7 |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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