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

Verified 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 1 week

Treatment 1 week

Follow Up 1 week

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 ~ 1 week1 visit

Treatment ~ 1 week2 visits

Follow Up ~ 1 week1 visit

Screening ~ 1 week

Treatment ~ 1 week

Follow Up ~1 week

This trial's timeline: 1 week for screening, 2 visits that are 1 week apart for treatment, and 1 week for reporting. There is also an open label period where patients will have the opportunity to use Fasedienol in everyday life prior to stressful situations or events up to 12 months.