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OpenTrials
Completed

NCT Number: NCT04800237

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

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Key information

Conditions

Performance Anxiety Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Tempe, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VQW-765

Drug

oral capsule

Placebo

Drug

oral capsule

Primary outcomes

  1. Subjective Units of Distress Scale (SUDS)

    Time frame: 1 Day

Secondary outcomes

  1. Clinician Global Impression of Change (CGI-C) scale at visit 2

    Time frame: 1 Day

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

    Time frame: 1 Day

  3. 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

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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