[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VistaGen Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100578275","phase-2-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-100578275",false,"NCT06809179","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","A Phase 2, Three-arm, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol (PH94B) Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension","Inclusion Criteria:\n\n* Written informed consent provided prior to conducting any study-specific assessment.\n* Male and female adults, 18 through 65 years of age, inclusive.\n* 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).\n* Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).\n* Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \\\u003C16.\n* 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\n* Subjects must have normal olfactory function\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n* 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.\n* 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.\n* Two or more documented failed adequate treatment trials with a registered medication approved for SAD.\n* Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.\n* Subjects taking psychotropic medications within 30 days before Visit 2.\n* 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.\n* Prior participation in a clinical trial involving fasedienol.\n* Participation in any other clinical trial within the last 30 days or during the course of the current trial.\n* Subjects with a positive urine drug screen.\n* Women who have a positive urine pregnancy test.\n* Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.\n* Subjects who have tested positive and\u002For have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).\n* 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.","ALL","18 Years","65 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27],"Social Anxiety Disorder",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Fasedienol","PH94B","social anxiety disorder","social anxiety","SAD","pherine","pherine nasal spray","acute treatment","anxiolytic","mental health","performance anxiety","anxiety nasal spray","anxiety treatment","public speaking anxiety","social phobia","phobic disorders","mental disorder","speech task","RECRUITING","2026-02-03",{"date":50,"type":51},"2026-02-05","ACTUAL",{"date":53,"type":51},"2025-01-09",{"date":55,"type":21},"2026-12",{"name":57,"class":58},"VistaGen Therapeutics, Inc.","INDUSTRY",9,""]