Actively Recruiting
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
Led by VistaGen Therapeutics, Inc. · Updated on 2026-02-05
60
Participants Needed
9
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any study assessments
- Adults aged 18 through 65 years
- Diagnosed with Social Anxiety Disorder as per DSM-5 and confirmed by MINI interview
- Liebowitz Social Anxiety Score of 70 or higher at screening
- Hamilton Depression Rating Scale (17 items) score less than 16
- Female participants of childbearing potential agree to use effective birth control during the study
- Normal sense of smell
You will not qualify if you...
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis, anorexia, bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder
- Current principal or personality disorder except specific phobias or generalized anxiety disorder if not primary diagnosis
- Moderate or severe alcohol use disorder in past year or illicit drug/THC use in past 2 months
- High risk of suicidal behavior or danger to self or others
- Significant nasal problems or surgeries affecting nasal chemosensory epithelium
- Two or more failed adequate treatment trials with approved medications for Social Anxiety Disorder
- Currently receiving cognitive-behavioral, exposure, or acceptance and commitment therapy
- Use of psychotropic medications within 30 days before second visit
- Use of OTC, prescription, off-label, CBD, or herbal products for anxiety within 30 days before second visit
- Prior participation in a fasedienol clinical trial
- Participation in any other clinical trial within 30 days or during this trial
- Positive urine drug screen
- Positive pregnancy test or currently breastfeeding unwilling to stop
- Symptoms or positive test for COVID-19 within 4 weeks before screening
- Any medical condition that could interfere with study or increase risk as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Vistagen Clinical Site
Sherman Oaks, California, United States, 91403
Actively Recruiting
2
Vistagen Clinical Site
Walnut Creek, California, United States, 94596
Actively Recruiting
3
Vistagen Clinical Site
Largo, Florida, United States, 33777
Actively Recruiting
4
Vistagen Clinical Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
5
Vistagen Clinical Site
Toms River, New Jersey, United States, 08755
Actively Recruiting
6
Vistagen Clinical Site
Cary, North Carolina, United States, 27511
Actively Recruiting
7
Vistagen Clinical Site
Cleveland, Ohio, United States, 44130
Terminated
8
Vistagen Clinical Site
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
9
Vistagen Clinical Site
Plano, Texas, United States, 75093
Terminated
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
3
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