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Fasedienol Nasal Spray for Social Anxiety Disorder (PALISADE-3 Trial)

Phase 3

Recruiting

Led By Michael Liebowitz, MD

Research Sponsored by VistaGen Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days (visit 2 to visit 3)

Awards & highlights

PALISADE-3 Trial Summary

"This trial will test the effectiveness, safety, and tolerance of a nasal spray called Fasedienol in reducing anxiety symptoms in adults aged 18-65 with Social Anxiety Disorder. The study will also

Who is the study for?

Adults aged 18-65 with Social Anxiety Disorder who experience anxiety during public speaking can join this trial. Participants must be able to use a nasal spray as needed, up to six times daily. Details on specific inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The trial is testing Fasedienol Nasal Spray against a placebo to see if it helps reduce acute anxiety symptoms quickly in social situations like public speaking. It's also looking at the long-term safety of using the spray up to six times a day for a year.See study design

What are the potential side effects?

Specific side effects of Fasedienol Nasal Spray aren't listed, but the study will monitor how safe and tolerable it is when used acutely or multiple times daily over an extended period.

PALISADE-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days (visit 2 to visit 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days (visit 2 to visit 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days (visit 2 to visit 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Subjective Units of Distress Scale (SUDS)

Secondary outcome measures

Global Impression Scale of Improvement (CGI-I)

Patient Global Impression of Change (PGI-C)

PALISADE-3 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fasedienol Nasal SprayExperimental Treatment1 Intervention

Group II: Placebo Nasal SprayPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VistaGen Therapeutics, Inc.Lead Sponsor

9 Previous Clinical Trials

1,349 Total Patients Enrolled

Michael Liebowitz, MDPrincipal InvestigatorMedical Research Network

3 Previous Clinical Trials

495 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are numerous sites in operation conducting this medical research study within the country of Canada?

"The current operation of this research is based at 5 sites, including Jacksonville, Orlando, and New york along with additional undisclosed locations. Opting for the nearest site can reduce travel burdens for participants."

Answered by AI

Is the clinical trial open to individuals who have reached or surpassed the age of 50?

"To be considered for enrollment in this investigation, individuals must have reached the age of 18 but not exceed 65 years."

Answered by AI

Is the recruitment phase still ongoing for potential participants in this clinical trial?

"As per clinicaltrials.gov, this trial is actively seeking candidates. The trial's initial posting was on March 28th, 2024, and its latest update was on April 4th of the same year."

Answered by AI

Is there a possibility for me to participate in this medical study?

"Individuals aged between 18 and 65 diagnosed with social anxiety disorder are sought for this research, aiming to enroll approximately 236 participants."

Answered by AI

What is the overall count of participants enrolled in this research endeavor?

"Indeed, the details on clinicaltrials.gov reveal that this research study is presently seeking volunteers. The trial was initially listed on March 28th, 2024 and last revised on April 4th, 2024. It aims to recruit a total of 236 participants from five distinct sites."

Answered by AI

Has the Fasedienol Nasal Spray received approval from the FDA?

"The safety assessment conducted by our team at Power rates Fasedienol Nasal Spray as a 3 on the scale due to its Phase 3 trial status, signifying existing efficacy data and extensive safety information."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)

2024. "Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06358651.

All > Anxiety Disorder > Social Anxiety