Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

Launched by VISTAGEN THERAPEUTICS, INC. · Sep 24, 2024

Keywords

ClinConnect Summary

The PALISADE-4 clinical trial is studying a new nasal spray called Fasedienol, which is aimed at helping adults with Social Anxiety Disorder (SAD) quickly relieve feelings of anxiety, especially in situations like public speaking. This study is for adults between the ages of 18 and 65 who have been diagnosed with SAD and experience significant anxiety during social situations. To qualify, participants must be able to provide written consent, have a specific score indicating their level of anxiety, and have no serious mental health disorders or significant issues with their sense of smell.

Participants in the trial will use the Fasedienol nasal spray as needed, up to six times a day, over a period of 12 months. They will be monitored for how well the spray works and whether it is safe for them to use. This study is currently looking for volunteers, and those who complete the initial phase may also choose to continue in an extended phase to further evaluate the spray's safety and effectiveness. If you or someone you know is struggling with social anxiety and meets the eligibility criteria, this could be an opportunity to help advance treatment options for this condition.

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, 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.