PH94B for Anxiety Disorders

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
VistaGen Investigational Site, Watertown, MA
Anxiety Disorders+2 More
PH94B - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)

See full description

Eligible Conditions

  • Anxiety Disorders
  • 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 will improve 2 primary outcomes in patients with Anxiety Disorders. Measurement will happen over the course of 12 months.

12 months
Adverse events and other safety measures
Liebowitz Social Anxiety Scale

Trial Safety

Safety Estimate

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

Trial Design

1 Treatment Group

PH94B 3.2 micrograms
1 of 1
Experimental Treatment

This trial requires 600 total participants across 1 different treatment group

This trial involves a single treatment. PH94B is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

PH94B 3.2 micrograms
Drug
100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PH94B
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

VistaGen Investigational Site - Watertown, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects who finish Palisade-1 (NCT047548020) and Palisade-2 (NCT05011396) will be in the study. show original
Women who might become pregnant during the study must be able to use contraception correctly and must have a negative pregnancy test before starting the study show original
All adults, regardless of sex or age, are eligible to participate. show original
is based on subjective judgement Social anxiety disorder is currently being diagnosed based on the judgement of a person's subjective experiences. show original
was associated with better antidepressant efficacy People who had a lower HAM-D17 total score at study entry had a better antidepressant efficacy. show original
If your LSAS score is 50 or greater, you may be eligible for accommodations on the LSAT. show original

Patient Q&A Section

How does ph94b work?

"Given these results, ph94b is expected to improve insomnia, anxiety, and depressive symptoms, and should be reconsidered as a novel treatment for insomnia. Ph94b may be a valuable new treatment for insomnia." - Anonymous Online Contributor

Unverified Answer

Can anxiety disorders be cured?

"Anxiety is a chronic and often debilitating condition with multiple underlying causes. Although treatment of anxiety disorder can be complex and challenging, people with anxiety disorder can be satisfied with the quality of the treatment received from mental health professionals, and many with long-term anxiety have good outcomes." - Anonymous Online Contributor

Unverified Answer

What are the signs of anxiety disorders?

"Anxiety can cause many symptoms such as feeling tense, short-tempered and irritable, a feeling of having low mood, muscle tension and shaking and palpitations and sweating. An increased level of worry in a new situation is also a sign of anxiety." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anxiety disorders?

"Anxiation disorders can be treated through a wide variety of therapies. Anxiety is often treated through CBT, behavioral therapy (BT), systematic-experimental therapy (SET), and/or prescription of sedative and anxiolytic medications.\n" - Anonymous Online Contributor

Unverified Answer

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

"Approximately 5.5 million people are estimated to have at least one anxiety disorder a year in the United States. This is slightly below the estimated 6.6 million new cases diagnosed annually (10.8 per 1,000 person-years). However, this estimate is based on the assumption of 1.5 new cases per year per anxiety disorder. This value, while not impossible, is unlikely and there is no compelling basis for assuming that the actual number of new cases will be that high. Given the large numbers of patients who will receive treatment for both anxiety and depression in the United States, these figures are not surprising." - Anonymous Online Contributor

Unverified Answer

What is anxiety disorders?

"Anxiety is a disorder of excessive, persistent fear or anxiety. It appears in a variety of forms such as phobias, agorias, work stress, and postpartum depression. Anxiety symptoms in women can range from stress-associated symptoms to panic attacks. Anxiety disorder is often mistaken medically and can be treated by using the right medication. One treatment option would be through exposure therapy by a trained technician.\n" - Anonymous Online Contributor

Unverified Answer

What causes anxiety disorders?

"There are many factors that might contribute to anxiety disorders. But none of these are entirely independent. Factors such as psychological, behavioural, and genetic/hereditary factors, such as emotional response to life events and childhood traumas, as well as biobehavioural factors including lifestyle choices have a significant impact on the development of a anxiety disorder. These factors are likely to act synergistically with stressful situations to a greater or lesser extent. Hence, there has been much debate in the research literature over the past forty years for and against the presence of psychological causes of specific anxiety disorders. Nevertheless, there has been a growing consensus in recent years that life stressors and stressful life events play a significant role in the development of anxiety." - Anonymous Online Contributor

Unverified Answer

How serious can anxiety disorders be?

"The majority of panic disorder patients reported their illness as an underlying cause to their condition in order to avoid further panic episodes. In addition, they frequently reported fear of social situations as a key symptom of panic disorder. Anxiety symptoms were correlated to higher symptom severity and a higher impact on health status. Treatment of panic disorder should focus on anxiety management." - Anonymous Online Contributor

Unverified Answer

Does ph94b improve quality of life for those with anxiety disorders?

"Compared to placebo, ph94b significantly improved depression, anxiety and stress levels in individuals with clinically relevant levels of anxiety for both men and women. The treatment effect seemed to be moderated by baseline gender and treatment status." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ph94b for therapeutic use?

"The current developments have been reviewed which include: further improvements to ph34b; further improvements to ph94b as a treatment of ph45a; and, the use of ph94b for various psychiatric conditions that have not so often been previously treated with ph94b." - Anonymous Online Contributor

Unverified Answer

Does anxiety disorders run in families?

"If a particular anxiety disorder runs in a pedigree, it is a reliable way of identifying whether an anxiety disorder is genetic and most likely to be related to a particular gene. Identifying the underlying cause and, eventually, the related gene will help shed light on the disease's pathogenesis. Anxiety disorders are a pervasive psychological problem in modern society, so this is an intriguing area for future genetic studies." - Anonymous Online Contributor

Unverified Answer

What is ph94b?

"The ph94b SNP may play a role in a higher rate of anxiety and depression symptom development. The ph94b/phy94c haplotype is a candidate gene for anxiety and depression." - 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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