Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
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
- Social Anxiety Disorder (SAD)
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VQW-765 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Vanda Investigational Site
Phoenix, Arizona 85012
Phoenix, Arizona 85012
Vanda Investigational Site
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Vanda Investigational Site
Encino, California 91316
Encino, California 91316
Vanda Investigational Site
Mission Viejo, California 92691
Mission Viejo, California 92691
Vanda Investigational Site
San Diego, California 92123
San Diego, California 92123
Vanda Investigational Site
San Jose, California 95124
San Jose, California 95124
Vanda Investigational Site
Walnut Creek, California 94596
Walnut Creek, California 94596
Vanda Investigational Site
Denver, Colorado 80209
Denver, Colorado 80209
Vanda Investigational Site
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Vanda Investigational Site
Miami, Florida 33125
Miami, Florida 33125
Vanda Investigational Site
Orlando, Florida 32801
Orlando, Florida 32801
Vanda Investigational Site
Tampa, Florida 33629
Tampa, Florida 33629
Vanda Investigational Site
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Vanda Investigational Site
Suwanee, Georgia 30024
Suwanee, Georgia 30024
Vanda Investigational Site
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Vanda Investigational Site
Pikesville, Maryland 21208
Pikesville, Maryland 21208
Vanda Investigational Site
Rockville, Maryland 20852
Rockville, Maryland 20852
Vanda Investigational Site
Saint Charles, Missouri 63304
Saint Charles, Missouri 63304
Vanda Investigational Site
St Louis, Missouri 63182
St Louis, Missouri 63182
Vanda Investigational Site
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Vanda Investigational Site
Princeton, New Jersey 08540
Princeton, New Jersey 08540
Vanda Investigational Site
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Vanda Investigational Site
New York, New York 10016
New York, New York 10016
Vanda Investigational Site
New York, New York 10036
New York, New York 10036
Vanda Investigational Site
Charlotte, North Carolina 28210
Charlotte, North Carolina 28210
Vanda Investigational Site
Wilmington, North Carolina 28403
Wilmington, North Carolina 28403
Vanda Investigational Site
Moosic, Pennsylvania 18507
Moosic, Pennsylvania 18507
Vanda Investigational Site
Houston, Texas 77081
Houston, Texas 77081
Vanda Investigational Site
Wichita Falls, Texas 76309
Wichita Falls, Texas 76309
Vanda Investigational Site
Orem, Utah 84097
Orem, Utah 84097
More Details
- Status
- Recruiting
- Sponsor
- Vanda Pharmaceuticals
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.