RecruitingPhase 3NCT07221578
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder
Sponsor
Vanda Pharmaceuticals
Enrollment
500 participants
Start Date
Sep 22, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria6
- Ability and willingness to provide written informed consent.
- Male and female subjects aged 18-65 years, inclusive.
- Current diagnosis of social anxiety disorder.
- Liebowitz Social Anxiety Scale total score ≥60.
- Public Speaking Anxiety Scale total score ≥60.
- Hamilton Depression Rating Scale score ≤18.
Exclusion Criteria8
- Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
- History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
- Posttraumatic stress disorder or an eating disorder in the past 6 months.
- Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
- Psychotherapy in the past 6 months.
- Psychotropic medication in the past 2 months.
- Current or planned pregnancy or nursing during the trial period.
- Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.
Interventions
DRUGVQW-765
oral capsule
DRUGPlacebo
oral capsule
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT07221578
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