Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety

Vanda Pharmaceuticals230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

230

Conditions

Performance Anxiety

Interventions

VQW-765DRUG

oral capsule

PlaceboDRUG

oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (15)

Vanda Investigational Site

Tempe, Arizona, United States

Vanda Investigational Site

Beverly Hills, California, United States

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

Time frame: 1 Day

Patient Global Impression of Change (PGI-C) scale at visit 2

Time frame: 1 Day

Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)

Time frame: 1 Day

Data from ClinicalTrials.gov

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