PH94B Nasal Spray for Social Anxiety Disorder
(Palisade-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a nasal spray called PH94B to determine its effectiveness in reducing anxiety for people with social anxiety disorder (SAD) during public speaking. Participants will use the nasal spray before facing a public speaking challenge to assess the spray's effectiveness. The trial seeks adults diagnosed with social anxiety disorder who frequently experience anxiety when speaking in front of others. As a Phase 3 trial, this study serves as the final step before potential FDA approval, providing participants an opportunity to contribute to the development of a new treatment for social anxiety disorder.
Do I need to stop taking my current medications to join the trial?
Yes, you will need to stop taking any psychotropic medications, anxiolytics (medications for anxiety), and any over-the-counter or herbal products for anxiety 30 days before joining the study and during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the PH94B nasal spray is generally safe. In earlier studies, only about 2.9% of participants stopped using the spray due to side effects like a stuffy nose or discomfort. Most other side effects were mild or moderate, such as slight irritation. Overall, most people can use the spray without problems. This information supports the safety of PH94B for treating anxiety.12345
Why do researchers think this study treatment might be promising for social anxiety disorder?
Unlike the standard treatments for anxiety, which often include oral medications like SSRIs and benzodiazepines, PH94B nasal spray offers a novel approach by acting directly through the nasal passages. This unique delivery method allows PH94B to potentially provide rapid relief from anxiety during public speaking, targeting the nasal chemosensory receptors to quickly influence brain regions involved in emotional processing. Researchers are excited because this intranasal spray could offer fast-acting anxiety relief without the systemic effects typically associated with oral medications, making it a promising option for situational anxiety.
What evidence suggests that this trial's treatments could be effective for social anxiety disorder?
Research has shown that PH94B nasal spray, which participants in this trial may receive, might help reduce anxiety symptoms related to social anxiety disorder (SAD). In a recent study, Vistagen found that the nasal spray successfully reduced anxiety during social situations. Early results suggest that the spray works quickly to calm nerves by reducing the body's stress response. This treatment is generally well-tolerated, with most people experiencing no serious side effects. Overall, PH94B appears to be a promising option for quick relief in anxiety-inducing situations like public speaking.678910
Who Is on the Research Team?
Michael Liebowitz
Principal Investigator
Medical Research Network
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 self-administer the nasal spray and participate in a 5-minute public speaking challenge
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeat safety and psychiatric assessments
What Are the Treatments Tested in This Trial?
Interventions
- PH94B Nasal Spray
- Placebo Nasal Spray
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo intranasal spray (100 microliters to each nostril) one time
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
Find a Clinic Near You
Who Is Running the Clinical Trial?
VistaGen Therapeutics, Inc.
Lead Sponsor
Citations
NCT02622958 | Feasibility Study of PH94B Nasal Spray for ...
The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in ...
Vistagen's Innovative Treatment for Social Anxiety
In the second half of 2023, Vistagen reported positive results from its PALISADE-2 Phase 3 trial of fasedienol in adults with SAD, with the trial meeting its ...
Effect of an acute intranasal aerosol dose of PH94B on ...
Conclusions: PH94B may be a novel, effective, and well-tolerated acute treatment for performance and social anxiety in women with social anxiety disorder. Trial ...
4.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05011396?term=AREA%5BBasicSearch%5D(palisade-2)&rank=1NCT05011396 | PH94B Nasal Spray for Anxiety Induced ...
This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve ...
Effect of fasedienol (PH94B) pherine nasal spray and ...
Results suggest that rapid onset of effects from fasedienol counteract heightened sympathetic activation and reduce symptoms of anxiety ...
Vistagen Presents Fasedienol (PH94B) Safety and ...
“These data advance the body of evidence supporting fasedienol's safety profile and potential to achieve overall reduction in anxiety for adults.
A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) ...
TEAE, treatment-emergent adverse event. • Fourteen patients (2.9%) experienced a TEAE leading to discontinuation. ─ Nasal congestion, rhinalgia, ...
PH94B in the Treatment of Adjustment Disorder With Anxiety
This placebo-controlled clinical study is designed to evaluate the efficacy, safety and tolerability of administration of PH94B nasal spray four times per ...
Intranasal Fasedienol Appears to Be Safe, Effective for ...
An evaluation of safety and tolerability showed that 54.9% of patients reported mild or moderate treatment emergent adverse events, with ...
Study Details | NCT06809179 | A Clinical Trial to Assess ...
A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With ...
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