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Active, not recruiting Phase 3

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

NCT07221578 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-09-22
Last updated
2026-08-17

Condition(s) studied

Social Anxiety Disorder (SAD)

Investigational drug(s) / intervention(s)

VQW-765Placebo

VQW-765: oral capsule

Placebo: oral capsule

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Ability and willingness to provide written informed consent. 2. Male and female subjects aged 18-65 years, inclusive. 3. Current diagnosis of social anxiety disorder. 4. Liebowitz Social Anxiety Scale total score ≥60. 5. Public Speaking Anxiety Scale total score ≥60. 6. Hamilton Depression Rating Scale score ≤18. Exclusion Criteria: 1. Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator. 2. History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder. 3. Posttraumatic stress disorder or an eating disorder in the past 6 months. 4. Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening. 5. Psychotherapy in the past 6 months. 6. Psychotropic medication in the past 2 months. 7. Current or planned pregnancy or nursing during the trial period. 8. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.

Primary outcome measure(s)

  • Subjective Units of Distress Scale (SUDS) — 1 day
    Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.

Trial sites (30)

FacilityCityRegionStatus
Vanda Investigational Site Phoenix Arizona
Vanda Investigational Site Scottsdale Arizona
Vanda Investigational Site Encino California
Vanda Investigational Site Mission Viejo California
Vanda Investigational Site San Diego California
Vanda Investigational Site San Jose California
Vanda Investigational Site Walnut Creek California
Vanda Investigational Site Denver Colorado
Vanda Investigational Site Jacksonville Florida
Vanda Investigational Site Miami Florida
Vanda Investigational Site Orlando Florida
Vanda Investigational Site Tampa Florida
Vanda Investigational Site Atlanta Georgia
Vanda Investigational Site Suwanee Georgia
Vanda Investigational Site New Orleans Louisiana
Vanda Investigational Site Pikesville Maryland
Vanda Investigational Site Rockville Maryland
Vanda Investigational Site Towson Maryland
Vanda Investigational Site Saint Charles Missouri
Vanda Investigational Site St Louis Missouri
Vanda Investigational Site Las Vegas Nevada
Vanda Investigational Site Princeton New Jersey
Vanda Investigational Site Albuquerque New Mexico
Vanda Investigational Site New York New York
Vanda Investigational Site New York New York
Vanda Investigational Site Charlotte North Carolina
Vanda Investigational Site Wilmington North Carolina
Vanda Investigational Site Houston Texas
Vanda Investigational Site Wichita Falls Texas
Vanda Investigational Site Orem Utah
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221578 on ClinicalTrials.gov ↗ ← All trials in the USA