PH94B Nasal Spray for Social Anxiety Disorder (SAD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
VistaGen Clinical Site, Garden Grove, CA
Social Anxiety Disorder (SAD)+2 More
PH94B Nasal Spray - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a nasal spray can help people with social anxiety disorder.

See full description

Eligible Conditions

  • Social Anxiety Disorder (SAD)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether PH94B Nasal Spray will improve 1 primary outcome and 1 secondary outcome in patients with Social Anxiety Disorder (SAD). Measurement will happen over the course of 20 minutes.

20 minutes
Clinical Global Impression - Improvement
Subjective Units of Distress Scale (SUDS)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

PH94B
1 of 2
Placebo
1 of 2
Experimental Treatment

This trial requires 208 total participants across 2 different treatment groups

This trial involves 2 different treatments. PH94B Nasal Spray is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

PH94B
Drug
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
Placebo
Drug
Placebo intranasal spray (100 microliters to each nostril) one time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PH94B
Not yet FDA approved
Placebo Nasal Spray
2006
Completed Phase 3
~3700

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 minutes
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 20 minutes for reporting.

Closest Location

VistaGen Clinical Site - Garden Grove, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People aged between 18 and 65 years old. show original
SAD is currently diagnosed by checking for symptoms in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirming those symptoms with the MINI. show original
The clinician rated the individual's LSAS total score as ≥70 at Screening. show original
The Hamilton Depression Score was less than eighteen at the screening visit. show original
Women who could potentially become pregnant must be able to commit to using birth control correctly for the entire study, and must also have a negative pregnancy test at both Screening and Baseline show original
Prior to conducting any study-specific assessment, the participant must provide written informed consent. show original
If you have recently been feeling ill with a fever, dry cough, shortness of breath, and body aches, or if you have been around someone who has been confirmed to have COVID-19, you should get a test for the virus show original

Patient Q&A Section

How many people get anxiety disorders a year in the United States?

"A total of 15 million Americans in the United States meet the criteria for an anxiety disorder. About 2 million people have persistent disabling anxiety at any given time, and over 5 million people are in long-term disability. The presence of another anxiety disorder increases the odds of the development of generalized anxiety disorder 5-fold. A third of those with one anxiety disorder meet criteria for another anxiety disorder in follow-up." - Anonymous Online Contributor

Unverified Answer

What causes anxiety disorders?

"A number of psychological, genetic, and environmental factors, particularly early negative life experiences, may cause anxiety. These factors may also influence the natural history of anxiety disorders and response to psychotherapeutic interventions, including psychodynamic therapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of anxiety disorders?

"People with anxiety disorders experience a variety of physical symptoms including abdominal, bowel and back pain, dyspepsia and irritable bowel syndrome. Anxious people also experience a variety of mental symptoms such as insomnia, palpitations, loss of appetite and restlessness. They may also feel as though the world is threatening to them and even experience panic attacks. People also may feel tense, afraid and anxious when they think about something that will happen or a memory that they have concerns over. They may have anxiety symptoms around panic attacks such as fear, shaking, shaking uncontrollably and shortness of breath. Anxiety symptoms vary but are present in the majority of people. However, some anxiety related symptoms only occur to certain people." - Anonymous Online Contributor

Unverified Answer

Can anxiety disorders be cured?

"Anxiety disorders are difficult to treat since each disorder is caused by a different set of mechanisms. As such, attempts to treat them by a single intervention or using a one-size-fits-all approach that does not take account of the complexity of the anxiety disorders does not result in a cure. However, with well-treating anxiety disorders, a cure and/or remission is possible and the most effective approach to preventing further episodes." - Anonymous Online Contributor

Unverified Answer

What is anxiety disorders?

"Anxiety disorders are the most frequently seen disorder among patients presenting with a psychiatric problem. Anxiety disorders have a huge and varying range of severity. Anxiety disorders are a group of disorders that often include a range of coexisting disorders. Anxiety disorders are treated with psychiatric techniques as well as physical treatments. \n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for anxiety disorders?

"Often overlooked is the potential for physical health issues if patients with anxiety disorders do not receive appropriate medical evaluation. When provided with appropriate psychotherapy, patients with anxiety disorders tend to respond well. Treatment usually is guided by an anxiety disorder and often requires psychosocial therapy. Physical manifestations often are seen as the result of anxiety disorders and/or excessive exercise." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of anxiety disorders?

"Anxiety disorders can arise from multiple factors and disorders, and the causes still remain uncertain. For anxiety disorder treatment, all disorders should be treated together and treated simultaneously, taking into consideration each patient's different symptoms and characteristics. In particular, it is important for anxiety disorder patients to treat the [dissociative disorders]. Anxiety disorder and the causes of it are complex. Although some studies have shown that anxiety disorder and the [dissociative disorders] are associated, it is better to not to exclude the fact that [dissociative disorders] may actually be associated with anxiety disorder in some cases." - Anonymous Online Contributor

Unverified Answer

How does ph94b nasal spray work?

"Ph94b nasal spray worked well in improving the overall symptoms of sneezing, runny nose and rhinorrhea in patients with chronic rhinosinusitis or chronic rhinitis without polyps." - Anonymous Online Contributor

Unverified Answer

Has ph94b nasal spray proven to be more effective than a placebo?

"Ph94b nasal spray, used to treat chronic rhinosinusitis in clinical trials, showed better symptom relief than a placebo, indicating a therapeutic effect with no adverse effects in patients with moderate to severe chronic rhinosinusitis. Results from a recent paper have potential value in developing a successful treatment for the common chronic rhinosinusitis." - Anonymous Online Contributor

Unverified Answer

Is ph94b nasal spray typically used in combination with any other treatments?

"For patients with [allergy](https://www.withpower.com/clinical-trials/allergy) or a specific phobia, nasal spray, preferably in combination with oral medication and/or a prescription of sedatives and anti-anxiety agents is recommended as the first-line treatment and other non-pharmacological means to alleviate anxiety symptoms. The effectiveness of this drug can be enhanced by other non-pharmacological therapeutic interventions, such as cognitive-behavioural therapy and psycho-education." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for anxiety disorders?

"Find a credible provider to help you decide if a clinical trial for an anxiety disorder is right for you. In particular, those with a history of anxiety may have more anxiety during a trial if they report more worry about how they are going to feel about participating." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating anxiety disorders?

"There are many new discoveries in the fields of psychotherapy and psychoeducation for treating anxiety disorders. First successful psychotherapeutic treatment of posttraumatic stress disorder using a psychosocial approach for the first time was performed by D. M. Corbo. Another study demonstrated that treatment with antidepressants was highly effective in the short-term maintenance of PTSD symptoms. In a recent study, findings support evidence of an etiological link between PTSD and depression. Additionally, many studies emphasize a significant association between anxiety disorders and substance abuse. Many psychological techniques have been reported for treating these addiction-related disorders. Behavioral treatments for anxiety disorders, such as exposure, distraction, and cognitive behavior therapy, show greater success than traditional psychopharmacological treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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