Performance Anxiety
Conditions
Keywords
social phobia, social anxiety disorder
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.
Interventions
DRUGVQW-765
oral capsule
DRUGPlacebo
oral capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Units of Distress Scale (SUDS) | 1 Day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed