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NCT06358651RECRUITINGIRB Ready

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

(PALISADE-3)

Sponsored by VistaGen Therapeutics, Inc.

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 ยตg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.

Who Can Participate

Inclusion Criteria

Written informed consent provided prior to conducting any study specific assessment.
Male and female adults, 18 through 65 years of age, inclusive.
Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
Clinician-rated Liebowitz Social Anxiety Scale (LSAS) total score โ‰ฅ70 at Screening (Visit 1).
Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16.
Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
Subjects must have normal olfactory function

Exclusion Criteria

Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

236 participants

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Age Range

18 Years - 65 Years

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Gender

ALL

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Sponsor

VistaGen Therapeutics, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Phoenix

Arizona

Location available
View Phoenix location page
Unknown

Fayetteville

Arkansas

Location available
View Fayetteville location page
Unknown

Little Rock

Arkansas

Location available
View Little Rock location page
Unknown

Lafayette

California

Location available
View Lafayette location page
Unknown

Oceanside

California

Location available
View Oceanside location page
Unknown

Sherman Oaks

California

Location available
View Sherman Oaks location page
Unknown

Denver

Colorado

Location available
View Denver location page
Unknown

Cromwell

Connecticut

Location available
View Cromwell location page
Unknown

Jacksonville

Florida

Location available
View Jacksonville location page

๐Ÿ“ And 15 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Social Anxiety Disorder Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Social Anxiety Disorder Treatment Options in Phoenix, Arizona

If you're searching for Social Anxiety Disorder treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Fayetteville, Little Rock and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Social Anxiety Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 236 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Social Anxiety Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Social Anxiety Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Social Anxiety Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06358651. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.