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Active, not recruitingPhase 3

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

Key facts

Who runs it
Vanda Pharmaceuticals
Where
Albuquerque, Atlanta, Charlotte, Denver, Encino, Houston, Jacksonville, Las Vegas, Miami, Mission Viejo, New Orleans, New York, Orem, Orlando, Phoenix, Pikesville, Princeton, Rockville, Saint Charles, San Diego, San Jose, Scottsdale, St Louis, Suwanee, Tampa, Towson, Walnut Creek, Wichita Falls, and Wilmington, United StatesSee the 29 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
500 people, planned
Started
22 Sept 2025
Expected to end
Apr 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • VQW-765
  • Placebo
Record updated
17 August 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Psychotropic medication in the past 2 months
  • 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
  • Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator
  • Psychotherapy in the past 6 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 in United States

  • Albuquerque, New MexicoHospital not named in the registry
  • Atlanta, GeorgiaHospital not named in the registry
  • Charlotte, North CarolinaHospital not named in the registry
  • Denver, ColoradoHospital not named in the registry
  • Encino, CaliforniaHospital not named in the registry
  • Houston, TexasHospital not named in the registry
  • Jacksonville, FloridaHospital not named in the registry
  • Las Vegas, NevadaHospital not named in the registry
  • Miami, FloridaHospital not named in the registry
  • Mission Viejo, CaliforniaHospital not named in the registry
  • New Orleans, LouisianaHospital not named in the registry
  • New YorkHospital not named in the registry
  • Orem, UtahHospital not named in the registry
  • Orlando, FloridaHospital not named in the registry
  • Phoenix, ArizonaHospital not named in the registry
  • Pikesville, MarylandHospital not named in the registry
  • Princeton, New JerseyHospital not named in the registry
  • Rockville, MarylandHospital not named in the registry
  • Saint Charles, MissouriHospital not named in the registry
  • San Diego, CaliforniaHospital not named in the registry
  • San Jose, CaliforniaHospital not named in the registry
  • Scottsdale, ArizonaHospital not named in the registry
  • St Louis, MissouriHospital not named in the registry
  • Suwanee, GeorgiaHospital not named in the registry
  • Tampa, FloridaHospital not named in the registry
  • Towson, MarylandHospital not named in the registry
  • Walnut Creek, CaliforniaHospital not named in the registry
  • Wichita Falls, TexasHospital not named in the registry
  • Wilmington, North CarolinaHospital not named in the registry

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • VQW-765Treatment being tested
  • PlaceboPlacebo, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
17 August 2026