Actively Recruiting
Fasedienol Nasal Spray for Acute Anxiety Treatment in Adults With Social Anxiety Disorder: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial With Open-Label Extension
Led by VistaGen Therapeutics, Inc. · Updated on 2026-02-05
60
Participants Needed
9
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the effects of Fasedienol Nasal Spray in adults aged 18 to 65 with Social Anxiety Disorder (SAD) triggered by a public speaking challenge. It is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study aiming to assess the safety, tolerability, and effectiveness of repeated intranasal doses of Fasedienol to relieve acute anxiety symptoms in a clinical setting. Participants will be randomly assigned to one of three groups: one receiving a dose of Fasedienol followed by a placebo spray, another receiving two doses of Fasedienol, and a third receiving two doses of placebo spray. The sprays are administered twenty minutes before the public speaking challenge, with ten minutes between doses. Those who complete this phase may enter an open-label extension where they can use Fasedienol as needed, up to six times daily for up to 12 months to assess longer-term safety and tolerability. During the study, participants will undergo assessments including the Subjective Units of Distress Scale (SUDS), Clinical Global Impression of Improvement (CGI-I), and Patient Global Impression of Change (PGI-C) over seven days. Researchers will monitor symptoms of anxiety, safety, and tolerability through clinical evaluations. The total participation timeline includes initial treatment and possible extended use with ongoing observation until the study ends in December 2026.
CONDITIONS
Brief 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, male and female
- Current diagnosis of Social Anxiety Disorder confirmed by a clinical interview
- Liebowitz Social Anxiety Score (LSAS) total score of at least 70 at screening
- Hamilton Depression Rating Scale (17-items) total score less than 16
- Female participants of childbearing potential must use effective birth control throughout 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
- Any other current primary or personality disorder except specific phobias or generalized anxiety disorder
- Moderate or severe alcohol use disorder in the past year or use of illicit substances or THC within 2 months before study entry
- Significant risk for suicidal behavior or considered a danger to self or others
- Significant nasal problems or history of nasal trauma, surgery, anosmia, or nasal septum perforation
- 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 Visit 2
- Use of any over-the-counter, prescription, off-label, cannabidiol, or herbal anxiety treatments within 30 days before Visit 2
- Prior participation in a clinical trial involving fasedienol
- Participation in any other clinical trial within 30 days or during this trial
- Positive urine drug screen
- Positive urine pregnancy test
- Currently breastfeeding and unwilling to stop during the study
- Symptoms or positive test for SARS-CoV-2 infection within 4 weeks before screening
- Any significant medical condition that could interfere with study or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day dosing with assessments over 7 days
Participants receive one or two doses of nasal spray (Fasedienol or placebo) prior to the public speaking challenge to assess acute treatment effects on anxiety.
2 visits (in-person): dosing visit and follow-up assessment visit
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.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here