Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiet… (NCT07221578) | Clinical Trial Compass
RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
United States500 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.