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

Primary Purpose

Performance Anxiety

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VQW-765
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Performance Anxiety focused on measuring social phobia, social anxiety disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VQW-765

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Subjective Units of Distress Scale (SUDS)

Secondary Outcome Measures

Clinician Global Impression of Change (CGI-C) scale at visit 2
Patient Global Impression of Change (PGI-C) scale at visit 2
Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)

Full Information

First Posted
March 10, 2021
Last Updated
September 1, 2022
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04800237
Brief Title
Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Performance Anxiety
Keywords
social phobia, social anxiety disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VQW-765
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VQW-765
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsule
Primary Outcome Measure Information:
Title
Subjective Units of Distress Scale (SUDS)
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Clinician Global Impression of Change (CGI-C) scale at visit 2
Time Frame
1 Day
Title
Patient Global Impression of Change (PGI-C) scale at visit 2
Time Frame
1 Day
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Vanda Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Vanda Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Vanda Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Vanda Investigational Site
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Vanda Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Vanda Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vanda Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Vanda Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Vanda Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Vanda Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Vanda Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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