Fasedienol Nasal Spray for treating anxiety in adults with Social Anxiety Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial evaluates the effectiveness, safety, and tolerability of Fasedienol Nasal Spray for alleviating acute anxiety symptoms in adults aged 18 to 65 diagnosed with Social Anxiety Disorder during a public speaking challenge. Participants will receive either the Fasedienol spray or a placebo, with the option to enter an open-label extension phase for additional treatment. The study aims to assess the nasal spray's impact on anxiety relief and its safety profile over a period of up to 12 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vistagen Clinical Site
  Phoenix, Arizona, United States Recruiting
• Vistagen Clinical Site
  Lafayette, California, United States Recruiting
• Vistagen Clinical Site
  Oceanside, California, United States Recruiting
• Vistagen Clinical Site
  Sherman Oaks, California, United States Recruiting
• Vistagen Clinical Site
  Cromwell, Connecticut, United States Recruiting
• Vistagen Clinical Site
  Lakeland, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Studies Vistagen Therapeutics, Inc.
• Email: clinicalstudies@vistagen.com
• Phone: 650-577-3693

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Stepped versus stratified care for anxiety in children and adolescents

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.