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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
Led by Vanda Pharmaceuticals · Updated on 2026-05-29
500
Participants Needed
30
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a single oral dose of VQW-765 compared to a placebo in adults with social anxiety disorder (SAD). This phase III, multicenter, randomized, double-blind, placebo-controlled study aims to assess how well VQW-765 works for on-demand treatment of acute anxiety in people diagnosed with SAD. Participants will be randomly assigned to receive either a single oral capsule of VQW-765 or a placebo capsule in a 1:1 ratio. After treatment, all participants will undergo a psychosocial stress test. Approximately 1 to 2 weeks later, a safety follow-up assessment will be conducted remotely to monitor any adverse effects or concerns. During the study, participants will be assessed using tools such as the Subjective Units of Distress Scale (SUDS) and the State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S) to measure anxiety levels. The research team will also track treatment-emergent adverse events over a 2-week period. The total involvement includes initial treatment, stress testing, and remote safety follow-up, ensuring thorough evaluation of both efficacy and safety.
CONDITIONS
Brief Title
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single oral dose of either VQW-765 or placebo, followed by a psychosocial stress test.
1 treatment visit (in-person)
Duration - 1 to 2 weeks after treatment
Participants complete a safety follow-up assessment conducted remotely.
1 remote follow-up visit
Trial Site Locations
Total: 30 locations
1
Vanda Investigational Site
Phoenix, Arizona, United States, 85012
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2
Vanda Investigational Site
Scottsdale, Arizona, United States, 85260
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3
Vanda Investigational Site
Encino, California, United States, 91316
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4
Vanda Investigational Site
Mission Viejo, California, United States, 92691
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5
Vanda Investigational Site
San Diego, California, United States, 92123
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6
Vanda Investigational Site
San Jose, California, United States, 95124
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7
Vanda Investigational Site
Walnut Creek, California, United States, 94596
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8
Vanda Investigational Site
Denver, Colorado, United States, 80209
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9
Vanda Investigational Site
Jacksonville, Florida, United States, 32256
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10
Vanda Investigational Site
Miami, Florida, United States, 33125
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11
Vanda Investigational Site
Orlando, Florida, United States, 32801
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12
Vanda Investigational Site
Tampa, Florida, United States, 33629
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13
Vanda Investigational Site
Atlanta, Georgia, United States, 30329
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14
Vanda Investigational Site
Suwanee, Georgia, United States, 30024
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15
Vanda Investigational Site
New Orleans, Louisiana, United States, 70115
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16
Vanda Investigational Site
Pikesville, Maryland, United States, 21208
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17
Vanda Investigational Site
Rockville, Maryland, United States, 20852
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18
Vanda Investigational Site
Saint Charles, Missouri, United States, 63304
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19
Vanda Investigational Site
St Louis, Missouri, United States, 63182
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20
Vanda Investigational Site
Las Vegas, Nevada, United States, 89102
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21
Vanda Investigational Site
Princeton, New Jersey, United States, 08540
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22
Vanda Investigational Site
Albuquerque, New Mexico, United States, 87109
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23
Vanda Investigational Site
New York, New York, United States, 10016
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24
Vanda Investigational Site
New York, New York, United States, 10036
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25
Vanda Investigational Site
Charlotte, North Carolina, United States, 28210
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26
Vanda Investigational Site
Wilmington, North Carolina, United States, 28403
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27
Vanda Investigational Site
Moosic, Pennsylvania, United States, 18507
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28
Vanda Investigational Site
Houston, Texas, United States, 77081
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29
Vanda Investigational Site
Wichita Falls, Texas, United States, 76309
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30
Vanda Investigational Site
Orem, Utah, United States, 84097
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Research Team
V
Vanda Pharmaceuticals, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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