Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)

Launched by VISTAGEN THERAPEUTICS, INC. · Apr 4, 2024

Keywords

ClinConnect Summary

The PALISADE-3 clinical trial is studying a new treatment called Fasedienol Nasal Spray for adults aged 18 to 65 who struggle with Social Anxiety Disorder (SAD), particularly in situations like public speaking. This trial aims to see how well the nasal spray works to quickly relieve feelings of anxiety, as well as how safe and tolerable it is for participants. Individuals who qualify will use the spray as needed, up to six times a day, for a period of up to 12 months, and those who complete the initial phase will have the option to continue in an extended part of the study.

To be eligible for this trial, participants must have a confirmed diagnosis of Social Anxiety Disorder and a specific level of anxiety as measured by a clinician. They must also be able to use effective birth control if they are women of childbearing age. However, people with certain mental health disorders, significant nasal issues, or those currently receiving specific therapies or medications will not be eligible. Participants can expect to receive close monitoring throughout the study and contribute to important research that could lead to better treatments for anxiety.

Gender

ALL

Eligibility criteria

• 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.