Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Social Anxiety Disorder (SAD)

In brief

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.

Key facts

Study ID

NCT07221578

Run by

Vanda Pharmaceuticals

People needed

500

Starts

2025-09-22

Expected to finish

2027-04-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — Towson, 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 — New York, New York, United States

Full record on ClinicalTrials.gov

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