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.
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.
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.
Vanda Pharmaceuticals
Lead sponsor