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
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.
