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

Social Anxiety Disorder (SAD)

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new on-demand medication called VQW-765 that people with social anxiety disorder would take only when needed — for example, before a public speaking event or social situation — rather than taking it every day. **You may be eligible if...** - You are between 18 and 65 years old - You have a current diagnosis of social anxiety disorder - Your social anxiety score is 60 or higher on standard rating scales - Your depression symptoms are mild (not severe) **You may NOT be eligible if...** - You have attempted suicide or had suicidal thoughts in the past 2 years - You have a history of bipolar disorder, schizophrenia, psychosis, seizures, OCD, or autism spectrum disorder - You have PTSD or an eating disorder in the past 6 months - You have had a substance or alcohol use disorder in the past 6 months - You have tested positive for drugs or alcohol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVQW-765

oral capsule

DRUGPlacebo

oral capsule

Locations(29)

Vanda Investigational Site

Phoenix, Arizona, United States

Vanda Investigational Site

Scottsdale, Arizona, United States

Vanda Investigational Site

Encino, California, United States

Vanda Investigational Site

Mission Viejo, 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

Denver, Colorado, United States

Vanda Investigational Site

Jacksonville, Florida, United States

Vanda Investigational Site

Miami, Florida, United States

Vanda Investigational Site

Orlando, Florida, United States

Vanda Investigational Site

Tampa, Florida, 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

Saint Charles, Missouri, United States

Vanda Investigational Site

St Louis, Missouri, United States

Vanda Investigational Site

Las Vegas, Nevada, United States

Vanda Investigational Site

Princeton, New Jersey, 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

Vanda Investigational Site

Moosic, Pennsylvania, United States

Vanda Investigational Site

Houston, Texas, United States

Vanda Investigational Site

Wichita Falls, Texas, United States

Vanda Investigational Site

Orem, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07221578

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