Social Anxiety Disorder (SAD)Phase 3PALISADE-4NCT06615557
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
A Phase 3 study testing Fasedienol Nasal Spray in people with Social Anxiety Disorder (SAD), run by VistaGen Therapeutics, Inc. at 26 sites in United States.
Trial summary
This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- Fasedienol Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 26 sitesUnited States
- Study dates
- 16 Sep 2024to 14 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Vistagen Clinical Site
Albuquerque, New Mexico, 87109
Vistagen Clinical Site
Austin, Texas, 78737
Vistagen Clinical Site
Austin, Texas, 78759
Vistagen Clinical Site
Bellflower, California, 90706
Vistagen Clinical Site
Bloomfield Township, Michigan, 48302
Vistagen Clinical Site
Boston, Massachusetts, 02131
Vistagen Clinical Site
Chicago, Illinois, 60640
Vistagen Clinical Site
Cincinnati, Ohio, 45229
Vistagen Clinical Site
Dallas, Texas, 75251
Vistagen Clinical Site
Decatur, Georgia, 30030
Vistagen Clinical Site
Denver, Colorado, 80209
Vistagen Clinical Site
Everett, Washington, 98201
Vistagen Clinical Site
Flowood, Mississippi, 39232
Vistagen Clinical Site
Houston, Texas, 77055
Vistagen Clinical Site
Las Vegas, Nevada, 89119
Vistagen Clinical Site
Las Vegas, Nevada, 89121
Vistagen Clinical Site
Little Rock, Arkansas, 72211
Vistagen Clinical Site
Naperville, Illinois, 60563
Vistagen Clinical Site
New York, New York, 10128
Vistagen Clinical Site
Oceanside, California, 92056
Vistagen Clinical Site
Orange, California, 92868
Vistagen Clinical Site
Phoenix, Arizona, 85012
Vistagen Clinical Site
Redlands, California, 92374
Vistagen Clinical Site
San Antonio, Texas, 78229
Vistagen Clinical Site
Tampa, Florida, 33629
Vistagen Clinical Site
Torrance, California, 90504
About this study
Official title: US, 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-4)
This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration 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 PALISADE-4 and choose to enter the distinct open-label extension phase of the study.
- Conditions
- Social Anxiety Disorder (SAD)
- Being tested
- Fasedienol Nasal Spray, Placebo Nasal Spray
- Keywords
- Fasedienol, PH94B, social anxiety disorder, social anxiety, SAD, pherine, pherine nasal spray, acute treatment, anxiolytic, mental health, anxiety, performance anxiety, anxiety nasal spray, anxiety treatment, public speaking anxiety, social phobia, phobic disorders, mental disorder, speech task
- Medical subject headings
- Phobia, Social, Psychological Well-Being, Anxiety Disorders, Phobic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasedienol Nasal SprayDrug
Nasal spray delivered 20 minutes before the PSC
Placebo Nasal SprayDrug
Nasal spray delivered 20 minutes before the PSC
| Study group | Role | What they receive |
|---|---|---|
| Fasedienol Nasal Spray | Experimental | Not described Receives: Drug: Fasedienol Nasal Spray |
| Placebo Nasal Spray | Experimental | Not described Receives: Drug: Placebo Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days (Visit 2 to Visit 3)
Secondary outcomes (2)
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.
Measured: 7 days (Visit 2 to Visit 3)
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.
Measured: 7 days (Visit 2 to Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start16 Sep 2024
- Primary completion21 Apr 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615557
- Sponsor's protocol ID
- PH94B-CL043
- Acronym
- PALISADE-4
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US, 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-4)
- ClinicalTrials.gov ID
- NCT06615557
- Acronym / sponsor ID
- PALISADE-4 / PH94B-CL043
- Conditions
- Social Anxiety Disorder (SAD)
- Keywords
- Fasedienol, PH94B, social anxiety disorder, social anxiety, SAD, pherine, pherine nasal spray, acute treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- VistaGen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration 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 PALISADE-4 and choose to enter the distinct open-label extension phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasedienol Nasal Spray | Experimental | Drug: Fasedienol Nasal Spray |
| Placebo Nasal Spray | Experimental | Drug: Placebo Nasal Spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasedienol Nasal SprayNasal spray delivered 20 minutes before the PSC | Drug | Fasedienol Nasal Spray |
| Placebo Nasal SprayNasal spray delivered 20 minutes before the PSC | Drug | Placebo Nasal Spray |
Primary outcome
Subjective Units of Distress Scale (SUDS)
Time frame: 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).
2 secondary outcomes
Global Impression Scale of Improvement (CGI-I)
Time frame: 7 days (Visit 2 to Visit 3)
Patient Global Impression of Change (PGI-C)
Time frame: 7 days (Visit 2 to Visit 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fasedienol Nasal Spray in people with Social Anxiety Disorder (SAD), run by VistaGen Therapeutics, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Units of Distress Scale (SUDS) (time frame: 7 days (Visit 2 to Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.