Status:
RECRUITING
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Social Anxiety Disorder (SAD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 disorde...
Detailed Description
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-76...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07221578
Start Date
September 22 2025
End Date
April 1 2027
Last Update
December 5 2025
Active Locations (20)
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1
Vanda Investigational Site
Phoenix, Arizona, United States, 85012
2
Vanda Investigational Site
Scottsdale, Arizona, United States, 85260
3
Vanda Investigational Site
Encino, California, United States, 91316
4
Vanda Investigational Site
Newport Beach, California, United States, 92660