Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety
- Registration Number
- NCT04800237
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief 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 male and female participants with performance anxiety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
- Ability and willingness to provide written informed consent.
- Sufficiently fluent in English to participate in the trial.
- Male and female patients aged 18-70 years (inclusive).
Exclusion Criteria
- Lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder.
- Current or planned pregnancy or nursing during the trial period.
- A positive test for substances of abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - VQW-765 VQW-765 -
- Primary Outcome Measures
Name Time Method Subjective Units of Distress Scale (SUDS) 1 Day
- Secondary Outcome Measures
Name Time Method Clinician Global Impression of Change (CGI-C) scale at visit 2 1 Day Patient Global Impression of Change (PGI-C) scale at visit 2 1 Day Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs) 1 Day
Trial Locations
- Locations (1)
Vanda Investigational Site
🇺🇸Houston, Texas, United States