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Fasedienol Nasal Spray for Social Anxiety Disorder (PALISADE-3 Trial)

Phase 3
Recruiting
Led By Michael Liebowitz, MD
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days (visit 2 to visit 3)
Awards & highlights

PALISADE-3 Trial Summary

"This trial will test the effectiveness, safety, and tolerance of a nasal spray called Fasedienol in reducing anxiety symptoms in adults aged 18-65 with Social Anxiety Disorder. The study will also

Who is the study for?
Adults aged 18-65 with Social Anxiety Disorder who experience anxiety during public speaking can join this trial. Participants must be able to use a nasal spray as needed, up to six times daily. Details on specific inclusion and exclusion criteria are not provided.Check my eligibility
What is being tested?
The trial is testing Fasedienol Nasal Spray against a placebo to see if it helps reduce acute anxiety symptoms quickly in social situations like public speaking. It's also looking at the long-term safety of using the spray up to six times a day for a year.See study design
What are the potential side effects?
Specific side effects of Fasedienol Nasal Spray aren't listed, but the study will monitor how safe and tolerable it is when used acutely or multiple times daily over an extended period.

PALISADE-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days (visit 2 to visit 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days (visit 2 to visit 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subjective Units of Distress Scale (SUDS)
Secondary outcome measures
Global Impression Scale of Improvement (CGI-I)
Patient Global Impression of Change (PGI-C)

PALISADE-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fasedienol Nasal SprayExperimental Treatment1 Intervention
Group II: Placebo Nasal SprayPlacebo Group1 Intervention

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Who is running the clinical trial?

VistaGen Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
1,349 Total Patients Enrolled
Michael Liebowitz, MDPrincipal InvestigatorMedical Research Network
3 Previous Clinical Trials
495 Total Patients Enrolled
~157 spots leftby Jun 2025
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