Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Social Anxiety Disorder (SAD)
• Intervention / Treatment: Drug: Placebo; Drug: VQW-765

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Vanda Pharmaceuticals, Inc.; Phone Number: 202-734-3400; Email: clinicaltrials@vandapharma.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Recruiting
      • Vanda Investigational Site
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Vanda Investigational Site
  • California
    • Encino, California, United States, 91316
      • Recruiting
      • Vanda Investigational Site
    • Mission Viejo, California, United States, 92691
      • Recruiting
      • Vanda Investigational Site
    • San Diego, California, United States, 92123
      • Recruiting
      • Vanda Investigational Site
    • San Jose, California, United States, 95124
      • Recruiting
      • Vanda Investigational Site
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Vanda Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80209
      • Recruiting
      • Vanda Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Vanda Investigational Site
    • Miami, Florida, United States, 33125
      • Recruiting
      • Vanda Investigational Site
    • Orlando, Florida, United States, 32801
      • Recruiting
      • Vanda Investigational Site
    • Tampa, Florida, United States, 33629
      • Recruiting
      • Vanda Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Vanda Investigational Site
    • Suwanee, Georgia, United States, 30024
      • Recruiting
      • Vanda Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Vanda Investigational Site
  • Maryland
    • Pikesville, Maryland, United States, 21208
      • Recruiting
      • Vanda Investigational Site
    • Rockville, Maryland, United States, 20852
      • Recruiting
      • Vanda Investigational Site
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Recruiting
      • Vanda Investigational Site
    • St Louis, Missouri, United States, 63182
      • Recruiting
      • Vanda Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Recruiting
      • Vanda Investigational Site
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Recruiting
      • Vanda Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Recruiting
      • Vanda Investigational Site
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Vanda Investigational Site
    • New York, New York, United States, 10036
      • Recruiting
      • Vanda Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Recruiting
      • Vanda Investigational Site
    • Wilmington, North Carolina, United States, 28403
      • Recruiting
      • Vanda Investigational Site
  • Pennsylvania
    • Moosic, Pennsylvania, United States, 18507
      • Recruiting
      • Vanda Investigational Site
  • Texas
    • Houston, Texas, United States, 77081
      • Recruiting
      • Vanda Investigational Site
    • Wichita Falls, Texas, United States, 76309
      • Recruiting
      • Vanda Investigational Site
  • Utah
    • Orem, Utah, United States, 84097
      • Recruiting
      • Vanda Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral capsule
Experimental: VQW-765	Drug: VQW-765; oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Units of Distress Scale (SUDS)	Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Units of Distress Scale (SUDS)	Subjective Units of Distress Scale (SUDS) during anticipation phase, scored from 0-100 with a higher score indicating higher distress.	1 day
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)	State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S), scored from 20 to 80 with higher scores indicating higher anxiety level.	1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Assessment of safety and tolerability of VQW-765, as measured by spontaneous reporting of adverse events (AEs)	2 weeks

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Social Phobia; Social Anxiety Disorder; SAD; Performance Anxiety; Public Speaking Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: VP-VQW-765-3201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No