Social Anxiety Disorder Self-Scheduler

Basic Criteria 

• Age 18-65 

• Symptoms related to social anxiety 

• Must be able to pass a drug screen 

Answers Must be NO 

• If female of childbearing potential, are you currently pregnant, breastfeeding, or planning to become pregnant? Ok to participate if willing to stop breastfeeding for duration of study. 

• Do you have any history of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrum disorder, or obsessive-compulsive disorder? 

• Have you been diagnosed with ADHD? 

• Do you have any other current principal or personality disorder (previously known as Axis I or Axis II disorders). Except for specific phobias or generalized anxiety disorder, if these are not the primary diagnosis. 

• In the past 1 year have you had moderate or severe alcohol use disorder?  

• In the past 2 months, have you used any illicit substances or THC? 

• In the past 2 years, have you had 1 or more suicidal attempts? 

• In the past 6 months, have you had any suicide thoughts? 

• Do you currently smoke more than 10 cigarettes per day or use e-cigarettes (“vaping”) daily? 

• Do you have any clinically significant nasal disease or history of significant nasal trauma, nasal surgery, total anosmia (sense of smell), or nasal septum perforation that may have damaged the nasal chemosensory epithelium? (Nose jobs are okay as long as no complications with loss of smell. Deviated septum surgery okay as long as no complications with loss of of smell.) 

• Do you currently have any acute or chronic condition (including an infectious illness, uncontrolled seasonal allergies, or significant nasal congestion) that potentially could affect drug delivery to the nasal chemosensory epithelium? 

• Have you ever failed 2 or more documented adequate treatment trials with a registered medication approved for social anxiety disorder such as Paroxetine(paxil), Venlafaxine (Effexor XR) or Sertraline (Zoloft)? 

• Are you currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy? (Marriage counseling is okay.) 

• In the past 30 days, have you taken any of the following psychotropic medications? antidepressants (including MAOIs), anxiolytics (including benzodiazepines), stimulants, anticonvulsants, mood stabilizers, antipsychotic medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine. 

• • Exceptions: Eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or antihistamines prescribed for insomnia are allowed 

• Are you currently taking Topiramate?  

• Do you currently take propranolol for anxiety?  

• In the past 30 days, have you used any over-the-counter product, prescription product, off-label treatment such as beta blockers (except for daily use of hypertension and cardiac conditions), cannabidiol (“CBD”), or herbal preparation for treatment of the symptoms of anxiety or social anxiety? 

• In the past 30 days, have you taken benzodiazepines daily? 

• In the past 4 weeks, have you undergone a nasal swab procedure for any reason (e.g., SARS-CoV-2 testing, influenza testing, zinc nasal swabs)? 

•  In the past 4 weeks, have you tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection? 

• Are you currently taking testosterone supplements or receiving testosterone replacement therapy? 

• Have you previously participated in a clinical trial involving fasedienol? 

• Have you participated in any other clinical trial within the last 30 days or participated in any trial that includes a Public Speaking Challenge within the last 12 months? 

• Do you currently have HIV, stroke, congestive heart failure, uncontrolled diabetes mellitus, or any other medical condition or disease that could interfere with study participation? 

• Have you had any cancer and have not been in remission for at least 2 years? Basal cell skin cancers are not exclusionary. 

• Do you have a first-degree relative (i.e., parent, sibling, child) of a current employee of the study site, friend of study site staff, current employee, shareholder, or member of board of directors of Vistagen? 

Answers Must be YES 

• If female of childbearing potential, do you agree to use of an effective method of birth control throughout the study? 

• • condoms with spermicide (Male or female condoms) 

• • diaphragm with spermicide  

• • hormonal contraceptive agents (oral, transdermal, or injectable) 

• • implantable contraceptive devices  

• • exclusively same-sex sexual activity for at least 3 months prior to screening 

• • sexual abstinence as their preferred and usual lifestyle 

• Are you willing to abstain from consuming products containing taurine or glucuronolactone (e.g., energy drinks such as Red Bull®) during the trial as needed? 

• Are you willing to abstain from the use of intranasal medications as required during the trial? 

Compensation may be available for time and travel

Insurance is not required 

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 210-714-0067 

If you do not see an available appointment, please call 210-714-0067 for availability 

Transportation may be available. Call 210-714-0067