Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
NCT ID: NCT07221578
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-09-22
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VQW-765
VQW-765
oral capsule
Placebo
Placebo
oral capsule
Interventions
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VQW-765
oral capsule
Placebo
oral capsule
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Phoenix, Arizona, United States
Vanda Investigational Site
Scottsdale, Arizona, United States
Vanda Investigational Site
Encino, California, United States
Vanda Investigational Site
Newport Beach, California, United States
Vanda Investigational Site
San Diego, California, United States
Vanda Investigational Site
San Jose, California, United States
Vanda Investigational Site
Walnut Creek, California, United States
Vanda Investigational Site
Atlanta, Georgia, United States
Vanda Investigational Site
Suwanee, Georgia, United States
Vanda Investigational Site
New Orleans, Louisiana, United States
Vanda Investigational Site
Pikesville, Maryland, United States
Vanda Investigational Site
Rockville, Maryland, United States
Vanda Investigational Site
St Louis, Missouri, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Albuquerque, New Mexico, United States
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
Charlotte, North Carolina, United States
Vanda Investigational Site
Wilmington, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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VP-VQW-765-3201
Identifier Type: -
Identifier Source: org_study_id