VQW-765 for Social Anxiety Disorder

Recruiting at 17 trial locations

Overseen By Vanda Pharmaceuticals, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanda Pharmaceuticals

Must not be taking: Psychotropic medications

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, VQW-765, to determine if it reduces symptoms of social anxiety disorder, characterized by intense fear in social situations. Participants will receive either VQW-765 or a placebo (a pill resembling the medication but without the active ingredient) to compare outcomes. The trial aims to assess the safety and effectiveness of VQW-765 in easing anxiety in social settings. It seeks adults diagnosed with social anxiety disorder who experience significant anxiety during public speaking or social interactions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

Do I need to stop my current medications to join the trial?

Yes, you need to stop taking any psychotropic medications (drugs that affect your mind, emotions, or behavior) at least 2 months before joining the trial.

Is there any evidence suggesting that VQW-765 is likely to be safe for humans?

Research has shown that VQW-765 is likely safe based on earlier studies. One study found that the treatment's side effects were similar to those of a placebo, indicating minimal difference from taking a sugar pill. Additionally, no issues with thinking or memory were reported, suggesting that VQW-765 is generally well-tolerated. These findings are promising for those considering participation in a trial for this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for social anxiety disorder, such as SSRIs and cognitive-behavioral therapy, VQW-765 offers a new approach by acting on the brain's GABA receptors. Researchers are excited because this mechanism could potentially lead to faster relief of anxiety symptoms. Additionally, VQW-765 might provide an option for those who do not respond well to current treatments, broadening the possibilities for effectively managing social anxiety disorder.

What evidence suggests that VQW-765 might be an effective treatment for social anxiety disorder?

Research has shown that VQW-765, which participants in this trial may receive, may help treat social anxiety disorder. Previous studies have found that participants using this treatment often experience reduced anxiety levels. One study even found a strong link between taking the drug and positive results. VQW-765 works by affecting a specific receptor in the brain that helps calm anxiety. Early findings suggest this action might help lower anxiety symptoms in stressful situations. Overall, VQW-765 seems to be a promising option for managing social anxiety. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with social anxiety disorder. Participants must meet specific criteria to join, but these details are not provided here.

Inclusion Criteria

I am between 18 and 65 years old.

Ability and willingness to provide written informed consent

Current diagnosis of social anxiety disorder

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of VQW-765 or placebo, followed by a psychosocial stress test

1 day

Follow-up

A safety follow-up assessment is conducted remotely to monitor safety and effectiveness

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VQW-765

Trial Overview The study tests the effectiveness and safety of a single oral dose of VQW-765 compared to a placebo in treating social anxiety on-demand. It's conducted across multiple centers, where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.

How Is the Trial Designed?

Group I: VQW-765 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278049/

Efficacy and safety of an alpha 7-nicotinic acetylcholine ... Results. Subjects receiving VQW-765 showed a trend of improvement in intensity of anxiety, as measured by the SUDS, during the performance phase of a TSST ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07221578

Study to Evaluate the Efficacy and Safety of VQW-765 for ... 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 ...

3. prnewswire.com prnewswire.com/news-releases/vanda-pharmaceuticals-reports-results-in-a-phase-ii-clinical-study-of-vqw-765-in-the-treatment-of-acute-performance-anxiety-301692285.html

Vanda Pharmaceuticals Reports Results in a Phase II ... The observed significant relationship between exposure and clinical outcome further supports the hypothesis that VQW-765 could be effective in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40340771/

Efficacy and safety of an alpha 7-nicotinic acetylcholine ... This is the first study showing anxiolytic effect of an α7-nAChR agonist in humans. VQW-765 is a promising candidate to be developed for on-demand treatment ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165178125000368

A phase 2, placebo-controlled study to evaluate the ... PREVAIL was a placebo-controlled Phase 2 study of BNC210 for acute treatment of SAD. BNC210 displayed an overall favorable profile that has enabled Phase 3 ...

6. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-the-efficacy-and-safety-of-vqw-765-for-the-on-demand-treatment-of-social-anxiety-d

Study to Evaluate the Efficacy and Safety of VQW-765 for the ... This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 ...