Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)
NCT ID: NCT06358651
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
238 participants
INTERVENTIONAL
2024-03-28
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fasedienol Nasal Spray
Fasedienol Nasal Spray
Nasal spray delivered 20 minutes before the PSC
Placebo Nasal Spray
Placebo Nasal Spray
Nasal spray delivered 20 minutes before the PSC
Interventions
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Fasedienol Nasal Spray
Nasal spray delivered 20 minutes before the PSC
Placebo Nasal Spray
Nasal spray delivered 20 minutes before the PSC
Eligibility Criteria
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Inclusion Criteria
* Male and female adults, 18 through 65 years of age, inclusive.
* Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
* Clinician-rated Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at Screening (Visit 1).
* Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16.
* Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
* Subjects must have normal olfactory function
Exclusion Criteria
* Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
* Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry.
* In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others.
* Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
* Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
* Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
* Subjects taking psychotropic medications within 30 days before Visit 2
* Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
* Prior participation in a clinical trial involving fasedienol.
* Participation in any other clinical trial within the last 30 days or during the course of the current trial.
* Subjects with a positive urine drug screen.
* Women who have a positive urine pregnancy test.
* Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
* Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).
* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.
18 Years
65 Years
ALL
No
Sponsors
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VistaGen Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Vistagen Clinical Site
Phoenix, Arizona, United States
Vistagen Clinical Site
Fayetteville, Arkansas, United States
Vistagen Clinical Site
Little Rock, Arkansas, United States
Vistagen Clinical Site
Lafayette, California, United States
Vistagen Clinical Site
Oceanside, California, United States
Vistagen Clinical Site
Sherman Oaks, California, United States
Vistagen Clinical Site
Denver, Colorado, United States
Vistagen Clinical Site
Cromwell, Connecticut, United States
Vistagen Clinical Site
Jacksonville, Florida, United States
Vistagen Clinical Site
Lakeland, Florida, United States
Vistagen Clinical Site
Orlando, Florida, United States
Vistagen Clinical Site
West Palm Beach, Florida, United States
Vistagen Clinical Site
Chicago, Illinois, United States
Vistagen Clinical Site
Overland Park, Kansas, United States
Vistagen Clinical Site
Baltimore, Maryland, United States
Vistagen Clinical Site
Boston, Massachusetts, United States
Vistagen Clinical Site
Saint Charles, Missouri, United States
Vistagen Clinical Site
Las Vegas, Nevada, United States
Vistagen Clinical Site
New York, New York, United States
Vistagen Clinical Site
Media, Pennsylvania, United States
Vistagen Clinical Site
Memphis, Tennessee, United States
Vistagen Clinical Site
Fort Worth, Texas, United States
Vistagen Clinical Site
Draper, Utah, United States
Vistagen Clinical Site
Everett, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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PH94B-CL042
Identifier Type: -
Identifier Source: org_study_id
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