Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified May 2025 by VistaGen Therapeutics, Inc.
Sponsor
VistaGen Therapeutics, Inc.
Information Provided by (Responsible Party)
VistaGen Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT06358651
Other Study ID Numbers:
PH94B-CL042
First Submitted
April 3, 2024
First Posted
April 9, 2024
Last Update Posted
November 25, 2025
Last Verified
May 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Social Anxiety Disorder
Drug: Fasedienol Nasal SprayDrug: Placebo Nasal Spray

Study Design

Study TypeInterventional
Actual Enrollment238 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleUS, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-3)
Study Start DateMarch 27, 2024
Actual Primary Completion DateOctober 30, 2025
Actual Study Completion Date5mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Fasedienol Nasal Spray
Drug: Fasedienol Nasal Spray
Nasal spray delivered 20 minutes before the PSC
Placebo Nasal Spray
Drug: Placebo Nasal Spray
Nasal spray delivered 20 minutes before the PSC

Outcome Measures

Primary Outcome Measures
  1. Subjective Units of Distress Scale (SUDS)
    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).
Secondary Outcome Measures
  1. Global Impression Scale of Improvement (CGI-I)
    The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.
  2. Patient Global Impression of Change (PGI-C)
    The PGI-C is a patient self-rated scale to assess improvement. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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 (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 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.

Contacts and Locations

Sponsors and CollaboratorsVistaGen Therapeutics, Inc.
Locations
Vistagen Clinical Site | Phoenix Arizona, United States, 85012Vistagen Clinical Site | Fayetteville Arkansas, United States, 72703Vistagen Clinical Site | Little Rock Arkansas, United States, 72211Vistagen Clinical Site | Lafayette California, United States, 94549Vistagen Clinical Site | Oceanside California, United States, 92056Vistagen Clinical Site | Sherman Oaks California, United States, 91403Vistagen Clinical Site | Denver Colorado, United States, 80209Vistagen Clinical Site | Cromwell Connecticut, United States, 06416Vistagen Clinical Site | Jacksonville Florida, United States, 32256Vistagen Clinical Site | Lakeland Florida, United States, 33803Vistagen Clinical Site | Orlando Florida, United States, 32801Vistagen Clinical Site | West Palm Beach Florida, United States, 33407Vistagen Clinical Site | Chicago Illinois, United States, 60612Vistagen Clinical Site | Overland Park Kansas, United States, 66210Vistagen Clinical Site | Baltimore Maryland, United States, 21208Vistagen Clinical Site | Boston Massachusetts, United States, 02131Vistagen Clinical Site | Saint Charles Missouri, United States, 63304Vistagen Clinical Site | Las Vegas Nevada, United States, 89119Vistagen Clinical Site | New York New York, United States, 10128Vistagen Clinical Site | Media Pennsylvania, United States, 19063Vistagen Clinical Site | Memphis Tennessee, United States, 38119Vistagen Clinical Site | Fort Worth Texas, United States, 76104Vistagen Clinical Site | Draper Utah, United States, 84020Vistagen Clinical Site | Everett Washington, United States, 98201