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Purpose

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 adults with social anxiety disorder.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Ability and willingness to provide written informed consent. 2. Male and female subjects aged 18-65 years, inclusive. 3. Current diagnosis of social anxiety disorder. 4. Liebowitz Social Anxiety Scale total score ≥60. 5. Public Speaking Anxiety Scale total score ≥60. 6. Hamilton Depression Rating Scale score ≤18.

Exclusion Criteria

  1. Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator. 2. History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder. 3. Posttraumatic stress disorder or an eating disorder in the past 6 months. 4. Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening. 5. Psychotherapy in the past 6 months. 6. Psychotropic medication in the past 2 months. 7. Current or planned pregnancy or nursing during the trial period. 8. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VQW-765
  • Drug: VQW-765
    oral capsule
Placebo Comparator
Placebo
  • Drug: Placebo
    oral capsule

Recruiting Locations

Vanda Investigational Site
Phoenix, Arizona 85012

Vanda Investigational Site
Scottsdale, Arizona 85260

Vanda Investigational Site
Encino, California 91316

Vanda Investigational Site
Mission Viejo, California 92691

Vanda Investigational Site
San Diego, California 92123

Vanda Investigational Site
San Jose, California 95124

Vanda Investigational Site
Walnut Creek, California 94596

Vanda Investigational Site
Denver, Colorado 80209

Vanda Investigational Site
Jacksonville, Florida 32256

Vanda Investigational Site
Miami, Florida 33125

Vanda Investigational Site
Orlando, Florida 32801

Vanda Investigational Site
Tampa, Florida 33629

Vanda Investigational Site
Atlanta, Georgia 30329

Vanda Investigational Site
Suwanee, Georgia 30024

Vanda Investigational Site
New Orleans, Louisiana 70115

Vanda Investigational Site
Pikesville, Maryland 21208

Vanda Investigational Site
Rockville, Maryland 20852

Vanda Investigational Site
Saint Charles, Missouri 63304

Vanda Investigational Site
St Louis, Missouri 63182

Vanda Investigational Site
Las Vegas, Nevada 89102

Vanda Investigational Site
Princeton, New Jersey 08540

Vanda Investigational Site
Albuquerque, New Mexico 87109

Vanda Investigational Site
New York, New York 10016

Vanda Investigational Site
New York, New York 10036

Vanda Investigational Site
Charlotte, North Carolina 28210

Vanda Investigational Site
Wilmington, North Carolina 28403

Vanda Investigational Site
Moosic, Pennsylvania 18507

Vanda Investigational Site
Houston, Texas 77081

Vanda Investigational Site
Wichita Falls, Texas 76309

Vanda Investigational Site
Orem, Utah 84097

More Details

Status
Recruiting
Sponsor
Vanda Pharmaceuticals

Study Contact

Vanda Pharmaceuticals, Inc.
202-734-3400
clinicaltrials@vandapharma.com

Detailed Description

The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.