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Behavioural Intervention

Fasedienol Nasal Spray for Social Anxiety Disorder

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Phase 2

Waitlist Available

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

Must not have

In the past two weeks, have you felt sad or less interested in things most days?

Have you ever been diagnosed with OCD (Obsessive Compulsive Disorder)?

Timeline

Screening 1 week

Treatment 1 week

Follow Up 1 week

Summary

This Phase 2 clinical trial is designed to evaluate the Fasedienol Nasal Spray (fasedienol) for adults that are 18-65 who suffer from symptoms of social anxiety such as nervousness, worry or fear of judgement. In addition, there is an Open Label Extension phase of the study for patients that choose to participate where use of nasal spray for up to 12 months will be assessed.

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Who is the study for?

Adults aged 18-65 with symptoms of Social Anxiety. Participants must be able to use a nasal spray as needed, up to six times daily.Check my eligibility

What is being tested?

The trial is testing Fasedienol Nasal Spray against a placebo to see if it helps reduce Social Anxiety.See study design

What are the potential side effects?

You may have some unwanted side effects and symptoms as a result of study treatment with Fasedienol Nasal Spray. Consistent administration of Fasedienol inside your nose may increase the risk of local site reactions including: soreness inside your nose, runny nose, nasal irritation, nasal dryness, and nosebleeds. Overall, these occurred in less than 2% of subjects who have used Fasedienol Nasal Spray in previous clinical studies.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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In the past two weeks, have you felt sad or less interested in things most days?

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Have you ever been diagnosed with OCD (Obsessive Compulsive Disorder)?

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Have you ever been diagnosed with Bipolar Disorder?

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Do you smoke more than 10 cigarettes per day or use electronic cigarettes (e.g., "vaping") on a daily basis?

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In the past year, was there a period of time when you were using alcohol or recreational drugs daily?

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Have you ever been diagnosed with Schizophrenia?

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Have you tried 2 or more medications for social anxiety that did not work for you?

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Are you currently using benzodiazepines daily (such as Xanax, Klonopin, Ativan)? Answer NO if you are willing to stop

Timeline

Screening ~ 1 week1 visit

Treatment ~ 1 week2 visits

Follow Up ~ 1 week1 visit

Screening ~ 1 week

Treatment ~ 1 week

Follow Up ~1 week

This trial's timeline: 1 week for screening, 1 week for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subjective Units of Distress Scale (SUDS)

Secondary study objectives

Global Impression Scale of Improvement (CGI-I)

Patient Global Impression of Change (PGI-C)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Placebo Nasal SprayExperimental Treatment1 Intervention

Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses.

Group II: Fasedienol Nasal Spray (single dose)Experimental Treatment1 Intervention

Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses.

Group III: Fasedienol Nasal Spray (repeat dose)Experimental Treatment1 Intervention

Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses.

0 / 8Eligibility criteria met