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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04800237

Collaborator

(none)

220

Enrollment

Locations

Arms

15.2

Anticipated Duration (Months)

14.7

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Performance Anxiety	Drug: VQW-765 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 23, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: VQW-765

Drug: VQW-765

oral capsule

Placebo Comparator: Placebo

Drug: Placebo

oral capsule

Outcome Measures

Primary Outcome Measures

Subjective Units of Distress Scale (SUDS) [1 Day]

Secondary Outcome Measures

Clinician Global Impression of Change (CGI-C) scale at visit 2 [1 Day]
Patient Global Impression of Change (PGI-C) scale at visit 2 [1 Day]
Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs) [1 Day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	Tempe	Arizona	United States	85281
2	Vanda Investigational Site	Beverly Hills	California	United States	90212
3	Vanda Investigational Site	Garden Grove	California	United States	92845
4	Vanda Investigational Site	San Jose	California	United States	95124
5	Vanda Investigational Site	Torrance	California	United States	90502
6	Vanda Investigational Site	Orlando	Florida	United States	32816
7	Vanda Investigational Site	Boston	Massachusetts	United States	02114
8	Vanda Investigational Site	North Dartmouth	Massachusetts	United States	02747
9	Vanda Investigational Site	Las Vegas	Nevada	United States	89119
10	Vanda Investigational Site	Berlin	New Jersey	United States	08009
11	Vanda Investigational Site	New York	New York	United States	10016
12	Vanda Investigational Site	Staten Island	New York	United States	10312
13	Vanda Investigational Site	Raleigh	North Carolina	United States	27612
14	Vanda Investigational Site	Cincinnati	Ohio	United States	45212
15	Vanda Investigational Site	Houston	Texas	United States	77074

Sponsors and Collaborators

Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vanda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04800237

Other Study ID Numbers:

VP-VQW-765-2201

First Posted:

Mar 16, 2021

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vanda Pharmaceuticals

social phobia

social anxiety disorder

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 15, 2022