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.
The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Subjective Units of Distress Scale (SUDS)
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
Time frame: 1 day
Subjective Units of Distress Scale (SUDS)
Subjective Units of Distress Scale (SUDS) during anticipation phase, scored from 0-100 with a higher score indicating higher distress.
Time frame: 1 day
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S), scored from 20 to 80 with higher scores indicating higher anxiety level.
Time frame: 1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Assessment of safety and tolerability of VQW-765, as measured by spontaneous reporting of adverse events (AEs)
Time frame: 2 weeks
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