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

NCT ID: NCT04800237

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2022-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Performance Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VQW-765

Group Type EXPERIMENTAL

VQW-765

Intervention Type DRUG

oral capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral capsule

Interventions

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VQW-765

oral capsule

Intervention Type DRUG

Placebo

oral capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Tempe, Arizona, United States

Site Status

Vanda Investigational Site

Beverly Hills, California, United States

Site Status

Vanda Investigational Site

Garden Grove, California, United States

Site Status

Vanda Investigational Site

San Jose, California, United States

Site Status

Vanda Investigational Site

Torrance, California, United States

Site Status

Vanda Investigational Site

Orlando, Florida, United States

Site Status

Vanda Investigational Site

Boston, Massachusetts, United States

Site Status

Vanda Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

Vanda Investigational Site

Las Vegas, Nevada, United States

Site Status

Vanda Investigational Site

Berlin, New Jersey, United States

Site Status

Vanda Investigational Site

New York, New York, United States

Site Status

Vanda Investigational Site

Staten Island, New York, United States

Site Status

Vanda Investigational Site

Raleigh, North Carolina, United States

Site Status

Vanda Investigational Site

Cincinnati, Ohio, United States

Site Status

Vanda Investigational Site

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VP-VQW-765-2201

Identifier Type: -

Identifier Source: org_study_id

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