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Fasedienol Nasal Spray for Social Anxiety Disorder (PALISADE-4 Trial)

Phase 3
Recruiting
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female adults, 18 through 65 years of age, inclusive
Be older than 18 years old
Must not have
Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy
Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days (visit 2 to visit 3)
Awards & highlights
Pivotal Trial

Summary

"This trial will test the effectiveness and safety of a nasal spray called Fasedienol in reducing symptoms of acute anxiety in adults aged 18 to 65 with Social Anxiety Disorder triggered by public speaking.

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 if they continue into the study's extension phase.
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 how safe and tolerable the drug is when used multiple times a day for up to a year.
What are the potential side effects?
Possible side effects of Fasedienol Nasal Spray are not detailed here, but typically nasal sprays may cause irritation, sneezing, nosebleeds, or headaches. Long-term safety will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently undergoing therapy such as CBT, exposure therapy, or acceptance and commitment therapy.
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I have tested positive or shown symptoms of COVID-19 in the last 4 weeks.
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I am pregnant as confirmed by a urine test.
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I have tried at least two medications for SAD without success.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjective Units of Distress Scale (SUDS)
Secondary study objectives
Global Impression Scale of Improvement (CGI-I)
Patient Global Impression of Change (PGI-C)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo Nasal SprayExperimental Treatment1 Intervention
Group II: Fasedienol Nasal SprayExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Nasal Spray
2006
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

VistaGen Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,585 Total Patients Enrolled
~157 spots leftby Oct 2025
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