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

Performance Anxiety Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800237
• Other study ID #: VP-VQW-765-2201
• Status: Completed
• Phase: Phase 2
• Start date: February 23, 2021
• Est. completion date: August 2, 2022

Study information

• Verified date: March 2024
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Performance Anxiety

Intervention

Drug:
• VQW-765
oral capsule
• Placebo
oral capsule

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Berlin	New Jersey
United States	Vanda Investigational Site	Beverly Hills	California
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Cincinnati	Ohio
United States	Vanda Investigational Site	Garden Grove	California
United States	Vanda Investigational Site	Houston	Texas
United States	Vanda Investigational Site	Las Vegas	Nevada
United States	Vanda Investigational Site	New York	New York
United States	Vanda Investigational Site	North Dartmouth	Massachusetts
United States	Vanda Investigational Site	Orlando	Florida
United States	Vanda Investigational Site	Raleigh	North Carolina
United States	Vanda Investigational Site	San Jose	California
United States	Vanda Investigational Site	Staten Island	New York
United States	Vanda Investigational Site	Tempe	Arizona
United States	Vanda Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Units of Distress Scale (SUDS)		1 Day
Secondary	Clinician Global Impression of Change (CGI-C) scale at visit 2		1 Day
Secondary	Patient Global Impression of Change (PGI-C) scale at visit 2		1 Day
Secondary	Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)		1 Day