Actively Recruiting
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Led by VistaGen Therapeutics, Inc. · Updated on 2026-04-24
236
Participants Needed
26
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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-4 and choose to enter the distinct open-label extension phase of the study.
CONDITIONS
Official Title
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Social Anxiety Disorder as defined in the DSM-5 and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score of 70 or higher at Screening.
- Clinician-rated Hamilton Depression Rating Scale (HAM-D) total score less than 16.
- Female subjects of childbearing potential must commit to consistently and correctly using effective birth control throughout the study.
- Subjects must have normal sense of smell.
You will not qualify if you...
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.
- Any other current principal or personality disorder except specific phobias or generalized anxiety disorder if not primary diagnosis.
- Moderate or severe alcohol use disorder within 1 year before study entry or use of illicit substances or THC within 2 months before entry.
- Significant risk of suicidal behavior or considered an imminent danger to self or others.
- Significant nasal problems including pathology, trauma, surgery, total anosmia, or septum perforation affecting nasal chemosensory epithelium.
- Two or more failed adequate treatment trials with approved SAD medications.
- Currently receiving cognitive-behavioral therapy, exposure therapy, or acceptance and commitment therapy.
- Use of psychotropic medications within 30 days before Visit 2.
- Use of over-the-counter, prescription, off-label, CBD, or herbal anxiety treatments within 30 days before Visit 2.
- Prior participation in a fasedienol clinical trial.
- Participation in any other clinical trial within 30 days before or during this trial.
- Positive urine drug screen.
- Positive pregnancy test or currently breastfeeding unless willing to stop breastfeeding during the study.
- Tested positive for or showed symptoms of COVID-19 within 4 weeks before screening.
- Any clinically significant medical history or findings that could interfere with study objectives or participant safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Vistagen Clinical Site
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Vistagen Clinical Site
Little Rock, Arkansas, United States, 72211
Active, Not Recruiting
3
Vistagen Clinical Site
Bellflower, California, United States, 90706
Actively Recruiting
4
Vistagen Clinical Site
Oceanside, California, United States, 92056
Actively Recruiting
5
Vistagen Clinical Site
Orange, California, United States, 92868
Actively Recruiting
6
Vistagen Clinical Site
Redlands, California, United States, 92374
Active, Not Recruiting
7
Vistagen Clinical Site
Torrance, California, United States, 90504
Actively Recruiting
8
Vistagen Clinical Site
Denver, Colorado, United States, 80209
Actively Recruiting
9
Vistagen Clinical Site
Tampa, Florida, United States, 33629
Actively Recruiting
10
Vistagen Clinical Site
Decatur, Georgia, United States, 30030
Active, Not Recruiting
11
Vistagen Clinical Site
Chicago, Illinois, United States, 60640
Active, Not Recruiting
12
Vistagen Clinical Site
Naperville, Illinois, United States, 60563
Actively Recruiting
13
Vistagen Clinical Site
Boston, Massachusetts, United States, 02131
Actively Recruiting
14
Vistagen Clinical Site
Bloomfield Township, Michigan, United States, 48302
Terminated
15
Vistagen Clinical Site
Flowood, Mississippi, United States, 39232
Actively Recruiting
16
Vistagen Clinical Site
Las Vegas, Nevada, United States, 89119
Active, Not Recruiting
17
Vistagen Clinical Site
Las Vegas, Nevada, United States, 89121
Terminated
18
Vistagen Clinical Site
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
19
Vistagen Clinical Site
New York, New York, United States, 10128
Actively Recruiting
20
Vistagen Clinical Site
Cincinnati, Ohio, United States, 45229
Terminated
21
Vistagen Clinical Site
Austin, Texas, United States, 78737
Actively Recruiting
22
Vistagen Clinical Site
Austin, Texas, United States, 78759
Actively Recruiting
23
Vistagen Clinical Site
Dallas, Texas, United States, 75251
Actively Recruiting
24
Vistagen Clinical Site
Houston, Texas, United States, 77055
Actively Recruiting
25
Vistagen Clinical Site
San Antonio, Texas, United States, 78229
Actively Recruiting
26
Vistagen Clinical Site
Everett, Washington, United States, 98201
Actively Recruiting
Research Team
C
Clinical Studies Vistagen Therapeutics, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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