Clinical trial NCT04800237: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Performance Anxiety
Keywords: social phobia
social anxiety disorder
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Subjective Units of Distress Scale (SUDS)
timeFrame: 1 Day
Secondary outcomes:
measure: Clinician Global Impression of Change (CGI-C) scale at visit 2
timeFrame: 1 Day
measure: Patient Global Impression of Change (PGI-C) scale at visit 2
timeFrame: 1 Day
measure: Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)
timeFrame: 1 Day
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Vanda Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: Vanda Investigational Site
state: California
city: Garden Grove
country: United States
facility: Vanda Investigational Site
state: California
city: San Jose
country: United States
facility: Vanda Investigational Site
state: California
city: Torrance
country: United States
facility: Vanda Investigational Site
state: California
city: Orlando
country: United States
facility: Vanda Investigational Site
state: Florida
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: Staten Island
country: United States
facility: Vanda Investigational Site
state: New York
city: Raleigh
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
Study officials:
References: