A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder
Eligible age
18–65 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose 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 PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.
Sponsor: VistaGen Therapeutics, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Sherman Oaks · Walnut Creek
Largo
Saint Charles
Toms River
Cary
Cleveland
Plymouth Meeting
Plano
Source: ClinicalTrials.gov · NCT06809179 · last updated 2026-02-05