NCT07221578 · Vanda Pharmaceuticals
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
What this study is about
This is a conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study to evaluate the effectiveness and safety of a single taken by mouth dose of VQW-765 compared to placebo in adults with social anxiety disorder.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Encino, California
- Mission Viejo, California
- San Diego, California
- San Jose, California
- Walnut Creek, California
- Denver, Colorado
- Jacksonville, Florida
- Miami, Florida
- Orlando, Florida
- Tampa, Florida
And 18 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations