Social Anxiety Disorder (SAD)Phase 3NCT07221578
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
A Phase 3 study testing VQW-765 in people with Social Anxiety Disorder (SAD), run by Vanda Pharmaceuticals at 30 sites in United States.
Trial 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 adults with social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- VQW-765
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 30 sitesUnited States
- Study dates
- 22 Sep 2025to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent.
- Male and female subjects aged 18-65 years, inclusive.
- Current diagnosis of social anxiety disorder.
- Liebowitz Social Anxiety Scale total score ≥60.
- Public Speaking Anxiety Scale total score ≥60.
- Hamilton Depression Rating Scale score ≤18.
Who cannot join
- Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
- History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
- Posttraumatic stress disorder or an eating disorder in the past 6 months.
- Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
- Psychotherapy in the past 6 months.
- Psychotropic medication in the past 2 months.
- Current or planned pregnancy or nursing during the trial period.
- Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Vanda Investigational Site
Albuquerque, New Mexico, 87109
Vanda Investigational Site
Atlanta, Georgia, 30329
Vanda Investigational Site
Charlotte, North Carolina, 28210
Vanda Investigational Site
Denver, Colorado, 80209
Vanda Investigational Site
Encino, California, 91316
Vanda Investigational Site
Houston, Texas, 77081
Vanda Investigational Site
Jacksonville, Florida, 32256
Vanda Investigational Site
Las Vegas, Nevada, 89102
Vanda Investigational Site
Miami, Florida, 33125
Vanda Investigational Site
Mission Viejo, California, 92691
Vanda Investigational Site
New Orleans, Louisiana, 70115
Vanda Investigational Site
New York, New York, 10016
Vanda Investigational Site
New York, New York, 10036
Vanda Investigational Site
Orem, Utah, 84097
Vanda Investigational Site
Orlando, Florida, 32801
Vanda Investigational Site
Phoenix, Arizona, 85012
Vanda Investigational Site
Pikesville, Maryland, 21208
Vanda Investigational Site
Princeton, New Jersey, 08540
Vanda Investigational Site
Rockville, Maryland, 20852
Vanda Investigational Site
Saint Charles, Missouri, 63304
Vanda Investigational Site
San Diego, California, 92123
Vanda Investigational Site
San Jose, California, 95124
Vanda Investigational Site
Scottsdale, Arizona, 85260
Vanda Investigational Site
St Louis, Missouri, 63182
Vanda Investigational Site
Suwanee, Georgia, 30024
Vanda Investigational Site
Tampa, Florida, 33629
Vanda Investigational Site
Towson, Maryland, 21204
Vanda Investigational Site
Walnut Creek, California, 94596
Vanda Investigational Site
Wichita Falls, Texas, 76309
Vanda Investigational Site
Wilmington, North Carolina, 28403
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety Disorder (SAD)
- Being tested
- VQW-765, Placebo
- Keywords
- Social Anxiety Disorder, Social Phobia, SAD, Public Speaking Anxiety, Performance Anxiety
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VQW-765Drug
oral capsule
PlaceboDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| VQW-765 | Experimental | Not described Receives: Drug: VQW-765 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start22 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221578
- Sponsor's protocol ID
- VP-VQW-765-3201
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07221578
- Acronym / sponsor ID
- VP-VQW-765-3201
- Conditions
- Social Anxiety Disorder (SAD)
- Keywords
- Social Anxiety Disorder, Social Phobia, SAD, Public Speaking Anxiety, Performance Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VQW-765 | Experimental | Drug: VQW-765 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability and willingness to provide written informed consent.
- Male and female subjects aged 18-65 years, inclusive.
- Current diagnosis of social anxiety disorder.
- Liebowitz Social Anxiety Scale total score ≥60.
- Public Speaking Anxiety Scale total score ≥60.
Key exclusion criteria (8 listed)
- Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
- History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
- Posttraumatic stress disorder or an eating disorder in the past 6 months.
- Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
- Psychotherapy in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VQW-765oral capsule | Drug | VQW-765 |
| Placebooral capsule | Drug | Placebo |
Primary outcome
Subjective Units of Distress Scale (SUDS)
Time frame: 1 day
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
3 secondary outcomes
Subjective Units of Distress Scale (SUDS)
Time frame: 1 day
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)
Time frame: 1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VQW-765 in people with Social Anxiety Disorder (SAD), run by Vanda Pharmaceuticals at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Units of Distress Scale (SUDS) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.