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Active Not Recruiting NCT07221578

Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder

Conditions: Social Anxiety Disorder (SAD)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 500
Sponsor: Vanda Pharmaceuticals

Location: Vanda Investigational Site Phoenix Arizona

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07221578). StuddyBuddy aggregates publicly available trial information.