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

March 19, 2024 updated by: Vanda Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Vanda Investigational Site
    • California
      • Beverly Hills, California, United States, 90212
        • Vanda Investigational Site
      • Garden Grove, California, United States, 92845
        • Vanda Investigational Site
      • San Jose, California, United States, 95124
        • Vanda Investigational Site
      • Torrance, California, United States, 90502
        • Vanda Investigational Site
    • Florida
      • Orlando, Florida, United States, 32816
        • Vanda Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Vanda Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Vanda Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Vanda Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Vanda Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Vanda Investigational Site
      • Staten Island, New York, United States, 10312
        • Vanda Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Vanda Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Vanda Investigational Site
    • Texas
      • Houston, Texas, United States, 77074
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral capsule
Experimental: VQW-765
Drug: VQW-765
oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective Units of Distress Scale (SUDS)
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician Global Impression of Change (CGI-C) scale at visit 2
Time Frame: 1 Day
1 Day
Patient Global Impression of Change (PGI-C) scale at visit 2
Time Frame: 1 Day
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
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

August 2, 2022

Study Completion (Actual)

August 2, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VQW-765-2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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