NCT04800237
Completed
Phase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety
Overview
- Phase
- Phase 2
- Intervention
- VQW-765
- Conditions
- Performance Anxiety
- Sponsor
- Vanda Pharmaceuticals
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Subjective Units of Distress Scale (SUDS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
VQW-765
Intervention: VQW-765
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Subjective Units of Distress Scale (SUDS)
Time Frame: 1 Day
Secondary Outcomes
- 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)
Study Sites (1)
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