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
1 other identifier
interventional
500
1 country
29
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 disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2025
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 22, 2025
CompletedFirst Submitted
Initial submission to the registry
October 24, 2025
CompletedFirst Posted
Study publicly available on registry
October 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 13, 2026
March 1, 2026
1.2 years
October 24, 2025
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective Units of Distress Scale (SUDS)
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
1 day
Secondary Outcomes (3)
Subjective Units of Distress Scale (SUDS)
1 day
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)
1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
2 weeks
Study Arms (2)
VQW-765
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Vanda Investigational Site
Phoenix, Arizona, 85012, United States
Vanda Investigational Site
Scottsdale, Arizona, 85260, United States
Vanda Investigational Site
Encino, California, 91316, United States
Vanda Investigational Site
Mission Viejo, California, 92691, United States
Vanda Investigational Site
San Diego, California, 92123, United States
Vanda Investigational Site
San Jose, California, 95124, United States
Vanda Investigational Site
Walnut Creek, California, 94596, United States
Vanda Investigational Site
Denver, Colorado, 80209, United States
Vanda Investigational Site
Jacksonville, Florida, 32256, United States
Vanda Investigational Site
Miami, Florida, 33125, United States
Vanda Investigational Site
Orlando, Florida, 32801, United States
Vanda Investigational Site
Tampa, Florida, 33629, United States
Vanda Investigational Site
Atlanta, Georgia, 30329, United States
Vanda Investigational Site
Suwanee, Georgia, 30024, United States
Vanda Investigational Site
New Orleans, Louisiana, 70115, United States
Vanda Investigational Site
Pikesville, Maryland, 21208, United States
Vanda Investigational Site
Rockville, Maryland, 20852, United States
Vanda Investigational Site
Saint Charles, Missouri, 63304, United States
Vanda Investigational Site
St Louis, Missouri, 63182, United States
Vanda Investigational Site
Las Vegas, Nevada, 89102, United States
Vanda Investigational Site
Princeton, New Jersey, 08540, United States
Vanda Investigational Site
Albuquerque, New Mexico, 87109, United States
Vanda Investigational Site
New York, New York, 10036, United States
Vanda Investigational Site
Charlotte, North Carolina, 28210, United States
Vanda Investigational Site
Wilmington, North Carolina, 28403, United States
Vanda Investigational Site
Moosic, Pennsylvania, 18507, United States
Vanda Investigational Site
Houston, Texas, 77081, United States
Vanda Investigational Site
Wichita Falls, Texas, 76309, United States
Vanda Investigational Site
Orem, Utah, 84097, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2025
First Posted
October 28, 2025
Study Start
September 22, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share