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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanda Pharmaceuticals

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • VQW-765
  • Placebo

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators