Clinical Trials in the USA / NCT07221578
Active, not recruiting
Phase 3
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
NCT07221578 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Social Anxiety Disorder (SAD)
Investigational drug(s) / intervention(s)
VQW-765Placebo
VQW-765: oral capsule
Placebo: oral capsule
Study summary
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.
Eligibility
Inclusion Criteria:
1. Ability and willingness to provide written informed consent.
2. Male and female subjects aged 18-65 years, inclusive.
3. Current diagnosis of social anxiety disorder.
4. Liebowitz Social Anxiety Scale total score ≥60.
5. Public Speaking Anxiety Scale total score ≥60.
6. Hamilton Depression Rating Scale score ≤18.
Exclusion Criteria:
1. Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
2. History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
3. Posttraumatic stress disorder or an eating disorder in the past 6 months.
4. Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
5. Psychotherapy in the past 6 months.
6. Psychotropic medication in the past 2 months.
7. Current or planned pregnancy or nursing during the trial period.
8. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.
Primary outcome measure(s)
- Subjective Units of Distress Scale (SUDS) — 1 day
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| Vanda Investigational Site | Phoenix | Arizona | |
| Vanda Investigational Site | Scottsdale | Arizona | |
| Vanda Investigational Site | Encino | California | |
| Vanda Investigational Site | Mission Viejo | California | |
| Vanda Investigational Site | San Diego | California | |
| Vanda Investigational Site | San Jose | California | |
| Vanda Investigational Site | Walnut Creek | California | |
| Vanda Investigational Site | Denver | Colorado | |
| Vanda Investigational Site | Jacksonville | Florida | |
| Vanda Investigational Site | Miami | Florida | |
| Vanda Investigational Site | Orlando | Florida | |
| Vanda Investigational Site | Tampa | Florida | |
| Vanda Investigational Site | Atlanta | Georgia | |
| Vanda Investigational Site | Suwanee | Georgia | |
| Vanda Investigational Site | New Orleans | Louisiana | |
| Vanda Investigational Site | Pikesville | Maryland | |
| Vanda Investigational Site | Rockville | Maryland | |
| Vanda Investigational Site | Towson | Maryland | |
| Vanda Investigational Site | Saint Charles | Missouri | |
| Vanda Investigational Site | St Louis | Missouri | |
| Vanda Investigational Site | Las Vegas | Nevada | |
| Vanda Investigational Site | Princeton | New Jersey | |
| Vanda Investigational Site | Albuquerque | New Mexico | |
| Vanda Investigational Site | New York | New York | |
| Vanda Investigational Site | New York | New York | |
| Vanda Investigational Site | Charlotte | North Carolina | |
| Vanda Investigational Site | Wilmington | North Carolina | |
| Vanda Investigational Site | Houston | Texas | |
| Vanda Investigational Site | Wichita Falls | Texas | |
| Vanda Investigational Site | Orem | Utah |
More Vanda Pharmaceuticals trials in the USA
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07221578 on ClinicalTrials.gov ↗ ← All trials in the USA