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NCT06615557

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

Active, Not Recruiting
PHASE3Ages 18–65InterventionalTreatment
VistaGen Therapeutics, Inc.
~238 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Fasedienol Nasal SprayPlacebo Nasal Spray

At a glance

Recruiting sites
0 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subjective Units of Distress Scale (SUDS)
Measured over 7 days (Visit 2 to Visit 3)

Conditions

Social Anxiety Disorder (SAD)

Explore related trials

Social Anxiety Disorder

NCT06615557

Where you'd take part

This study runs at 26 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Vistagen Clinical Site

    Phoenix, Arizonano site contact published

  • Vistagen Clinical Site

    Little Rock, Arkansasno site contact published

  • Vistagen Clinical Site

    Bellflower, Californiano site contact published

  • Vistagen Clinical Site

    Oceanside, Californiano site contact published

  • Vistagen Clinical Site

    Orange, Californiano site contact published

  • Vistagen Clinical Site

    Redlands, Californiano site contact published

  • Vistagen Clinical Site

    Torrance, Californiano site contact published

  • Vistagen Clinical Site

    Denver, Coloradono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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 SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
Clinician-rated Liebowitz Social Anxiety Score (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

Any 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 (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.

What this trial measures

  • Subjective Units of Distress Scale (SUDS)7 days (Visit 2 to Visit 3)

    The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt).