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 (NCT06809179)
A Phase 2, Three-arm, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol (PH94B) 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
🩺 Plain-English Summary (8th-Grade Level)
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose 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 PH94B-CL036 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 — Sherman Oaks, California
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 (9 Sites)
- Vistagen Clinical Site — Sherman Oaks, California
- Vistagen Clinical Site — Walnut Creek, California
- Vistagen Clinical Site — Largo, Florida
- Vistagen Clinical Site — Saint Charles, Missouri
- Vistagen Clinical Site — Toms River, New Jersey
- Vistagen Clinical Site — Cary, North Carolina
- Vistagen Clinical Site — Cleveland, Ohio
- Vistagen Clinical Site — Plymouth Meeting, Pennsylvania
- Vistagen Clinical Site — Plano, Texas
📞 Contact the Study Coordinator
Phone: (650) 577-3693
Email: clinicalstudies@vistagen.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) — Phoenix, Arizona
- Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder — Charleston, South Carolina
- 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.