PH94B for Social Anxiety Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a nasal spray called PH94B for individuals with social anxiety disorder (SAD). Participants will use the spray up to four times daily in anxiety-inducing situations. The trial aims to determine if the treatment is safe and well-tolerated over a year. Individuals with a current diagnosis of social anxiety disorder who experience it in their daily lives might be suitable for this trial. 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 have to stop taking my current medications for the trial?
You may need to stop certain medications to join the trial. Specifically, you cannot use certain psychotropic medications, anxiolytics (like benzodiazepines), or treatments for anxiety within 30 days before starting the study and during the study. However, if you are on antidepressants or buspirone, you can continue them if you've been on a stable dose for at least a month.
Is there any evidence suggesting that PH94B is likely to be safe for humans?
Research shows that PH94B, a nasal spray for social anxiety disorder, is safe for use. Studies have found that patients generally tolerate PH94B well when used as needed. These studies have reported no major safety issues, increasing confidence in its safety.
Some studies noted that patients experienced only mild side effects, if any. This suggests that PH94B can be used several times a day without significant risk. This is encouraging for those considering joining a clinical trial, as existing data supports its safety for repeated use.12345Why do researchers think this study treatment might be promising?
Unlike traditional treatments for social anxiety disorder, which often involve oral medications like SSRIs or benzodiazepines, PH94B is a nasal spray that provides rapid relief from acute anxiety. Researchers are excited about PH94B because it acts directly on nasal chemosensory receptors, potentially offering faster results without the systemic side effects common in oral medications. This unique delivery method allows for on-demand usage, giving individuals more control over their anxiety symptoms as they arise.
What evidence suggests that PH94B might be an effective treatment for anxiety?
Research has shown that PH94B, also known as fasedienol, holds promise as a treatment for social anxiety disorder. Studies found that people using PH94B experienced significantly less anxiety than those who took a placebo, a substance with no active medicine. This nasal spray quickly calms the body's "fight or flight" response, which often activates during stressful situations. In recent trials, many participants reported feeling much better after using PH94B. These results suggest that PH94B could be a safe and effective way to manage social anxiety.678910
Who Is on the Research Team?
Jaakko Lappalainen, MD, PhD
Principal Investigator
VistaGen Therapeutics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use PH94B nasal spray up to 4 times a day for anxiety-provoking situations over 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PH94B
Find a Clinic Near You
Who Is Running the Clinical Trial?
VistaGen Therapeutics, Inc.
Lead Sponsor