← Back to searchRecruitingRecruiting
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
NCT07221578 · Vanda Pharmaceuticals
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.
Eligibility criteria
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.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-22
Estimated completion: 2027-04
Last updated: 2026-04-13
Interventions
Drug: VQW-765Drug: Placebo
Primary outcomes
- • Subjective Units of Distress Scale (SUDS) (1 day)
Sponsor
Vanda Pharmaceuticals · industry
Contacts & investigators
ContactVanda Pharmaceuticals, Inc. · contact · clinicaltrials@vandapharma.com · 202-734-3400
All locations (29)
Vanda Investigational SiteRecruiting
Phoenix, Arizona, United States
Vanda Investigational SiteRecruiting
Scottsdale, Arizona, United States
Vanda Investigational SiteRecruiting
Encino, California, United States
Vanda Investigational SiteRecruiting
Mission Viejo, California, United States
Vanda Investigational SiteRecruiting
San Diego, California, United States
Vanda Investigational SiteRecruiting
San Jose, California, United States
Vanda Investigational SiteRecruiting
Walnut Creek, California, United States
Vanda Investigational SiteRecruiting
Denver, Colorado, United States
Vanda Investigational SiteRecruiting
Jacksonville, Florida, United States
Vanda Investigational SiteRecruiting
Miami, Florida, United States
Vanda Investigational SiteRecruiting
Orlando, Florida, United States
Vanda Investigational SiteRecruiting
Tampa, Florida, United States
Vanda Investigational SiteRecruiting
Atlanta, Georgia, United States
Vanda Investigational SiteRecruiting
Suwanee, Georgia, United States
Vanda Investigational SiteRecruiting
New Orleans, Louisiana, United States
Vanda Investigational SiteRecruiting
Pikesville, Maryland, United States
Vanda Investigational SiteRecruiting
Rockville, Maryland, United States
Vanda Investigational SiteRecruiting
Saint Charles, Missouri, United States
Vanda Investigational SiteRecruiting
St Louis, Missouri, United States
Vanda Investigational SiteRecruiting
Las Vegas, Nevada, United States
Vanda Investigational SiteRecruiting
Princeton, New Jersey, United States
Vanda Investigational SiteRecruiting
Albuquerque, New Mexico, United States
Vanda Investigational SiteRecruiting
New York, New York, United States
Vanda Investigational SiteRecruiting
Charlotte, North Carolina, United States
Vanda Investigational SiteRecruiting
Wilmington, North Carolina, United States
Vanda Investigational SiteRecruiting
Moosic, Pennsylvania, United States
Vanda Investigational SiteRecruiting
Houston, Texas, United States
Vanda Investigational SiteRecruiting
Wichita Falls, Texas, United States
Vanda Investigational SiteRecruiting
Orem, Utah, United States