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Tests treatment safety and results for Social Anxiety Disorder
Official title 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
ClinicalTrials.gov ID: NCT06809179
What this study is testing
What is Fasedienol Nasal Spray - Fasedienol Nasal Spray?
Fasedienol Nasal Spray - Fasedienol Nasal Spray is an investigational medicine, being studied as a potential treatment for social anxiety disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder...
- Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized...
- people 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...
- In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study...
- Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may...
- Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
See the full eligibility 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 people of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
- people must have normal olfactory function
- 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.
- people 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...
- 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.
- people 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.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sherman Oaks, California, United States
- Walnut Creek, California, United States
- Largo, Florida, United States
- Saint Charles, Missouri, United States
- Toms River, New Jersey, United States
- Cary, North Carolina, United States
- Cleveland, Ohio, United States
- Plymouth Meeting, Pennsylvania, United States
- Plano, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherman Oaks, California, United States; Walnut Creek, California, United States; Largo, Florida, United States; Saint Charles, Missouri, United States; Toms River, New Jersey, United States; Cary, North Carolina, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.