Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) (NCT06358651)
US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-3)
🩺 Plain-English Summary (8th-Grade Level)
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 µg) 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 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study.
Who can join: Review the eligibility criteria below.
Location: Vistagen Clinical Site — Phoenix, Arizona
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Vistagen Clinical Site — Phoenix, Arizona
- Vistagen Clinical Site — Fayetteville, Arkansas
- Vistagen Clinical Site — Little Rock, Arkansas
- Vistagen Clinical Site — Lafayette, California
- Vistagen Clinical Site — Oceanside, California
- Vistagen Clinical Site — Sherman Oaks, California
- Vistagen Clinical Site — Denver, Colorado
- Vistagen Clinical Site — Cromwell, Connecticut
- Vistagen Clinical Site — Jacksonville, Florida
- Vistagen Clinical Site — Lakeland, Florida
- Vistagen Clinical Site — Orlando, Florida
- Vistagen Clinical Site — West Palm Beach, Florida
- Vistagen Clinical Site — Chicago, Illinois
- Vistagen Clinical Site — Overland Park, Kansas
- Vistagen Clinical Site — Baltimore, Maryland
- Vistagen Clinical Site — Boston, Massachusetts
- Vistagen Clinical Site — Saint Charles, Missouri
- Vistagen Clinical Site — Las Vegas, Nevada
- Vistagen Clinical Site — New York, New York
- Vistagen Clinical Site — Media, Pennsylvania
- Vistagen Clinical Site — Memphis, Tennessee
- Vistagen Clinical Site — Fort Worth, Texas
- Vistagen Clinical Site — Draper, Utah
- Vistagen Clinical Site — Everett, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Social Anxiety Disorder
- Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder — Charleston, South Carolina
- A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder — Sherman Oaks, California
- Computer - Based Treatment for Social Anxiety Disorder — New York, New York
- Individual Factors of CBT Underlying Success — Seattle, Washington
- Group Exposure Workshops for Socially Anxious Undergraduates — Boulder, Colorado
Explore by condition: All Social Anxiety Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.