New nasal spray could take the edge off public speaking anxiety
NCT ID NCT06809179
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a nasal spray called fasedienol can quickly reduce anxiety in people with social anxiety disorder when they have to speak in public. Sixty adults will receive either the spray, a combination, or a placebo before a speech challenge. The goal is to see if it helps them feel less distressed in the moment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fasedienol nasal spray
- What this could lead to
- If it works, this could offer a fast-acting, on-demand nasal spray to ease anxiety before stressful events like public speaking.
- What could go wrong
- This is an early phase 2 trial with only 60 people, so results may not apply widely. The effect may be small or no better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vistagen Clinical Site
RECRUITINGSherman Oaks, California, 91403, United States
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Vistagen Clinical Site
RECRUITINGWalnut Creek, California, 94596, United States
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Vistagen Clinical Site
RECRUITINGLargo, Florida, 33777, United States
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Vistagen Clinical Site
RECRUITINGSaint Charles, Missouri, 63304, United States
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Vistagen Clinical Site
RECRUITINGToms River, New Jersey, 08755, United States
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Vistagen Clinical Site
RECRUITINGCary, North Carolina, 27511, United States
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Vistagen Clinical Site
TERMINATEDCleveland, Ohio, 44130, United States
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Vistagen Clinical Site
RECRUITINGPlymouth Meeting, Pennsylvania, 19462, United States
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Vistagen Clinical Site
TERMINATEDPlano, Texas, 75093, United States
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