NCT04800237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 10, 2021

Last Update Submit

March 19, 2024

Conditions

Performance Anxiety

Keywords

social phobiasocial anxiety disorder

Outcome Measures

Primary Outcomes (1)

  • Subjective Units of Distress Scale (SUDS)

    1 Day

Secondary Outcomes (3)

  • 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

Study Arms (2)

VQW-765

EXPERIMENTAL
Drug: VQW-765

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VQW-765DRUG

oral capsule

VQW-765
PlaceboDRUG

oral capsule

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Vanda Investigational Site

Tempe, Arizona, 85281, United States

Location

Vanda Investigational Site

Beverly Hills, California, 90212, United States

Location

Vanda Investigational Site

Garden Grove, California, 92845, United States

Location

Vanda Investigational Site

San Jose, California, 95124, United States

Location

Vanda Investigational Site

Torrance, California, 90502, United States

Location

Vanda Investigational Site

Orlando, Florida, 32816, United States

Location

Vanda Investigational Site

Boston, Massachusetts, 02114, United States

Location

Vanda Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Vanda Investigational Site

Las Vegas, Nevada, 89119, United States

Location

Vanda Investigational Site

Berlin, New Jersey, 08009, United States

Location

Vanda Investigational Site

New York, New York, 10016, United States

Location

Vanda Investigational Site

Staten Island, New York, 10312, United States

Location

Vanda Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Vanda Investigational Site

Cincinnati, Ohio, 45212, United States

Location

Vanda Investigational Site

Houston, Texas, 77074, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 16, 2021

Study Start

February 23, 2021

Primary Completion

August 2, 2022

Study Completion

August 2, 2022

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(15)