Phase
Condition
Social Anxiety Disorder (Sad)
Anxiety Disorders
Panic Disorders
Treatment
BVR-100
BES-100
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is male or female, aged 18 or above.
Subject has English fluency and literacy.
Subject meets the Diagnostic and Statistical Manual of Mental Disorders, FifthEdition, (DSM-5) criteria for Social Anxiety Disorder
Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥
Exclusion
Exclusion Criteria:
Subject has significant visual, auditory or balance impairment
Subject has history of photosensitive epilepsy or seizure disorder
Subject has history of motion sickness or medical condition predisposing to nauseaor dizziness.
Subject has injuries, inflammation or infection affecting the eyes, ears or facethat would make the use of the hardware uncomfortable.
Subject has, current or lifetime history of meeting DSM-5 criteria for schizophreniaspectrum or other psychotic disorder, bipolar or related disorder, majorneurocognitive disorder, neurodevelopmental disorder of greater than mild severityor of a severity that impacts the subject's ability to consent, follow studydirections, or otherwise safely participate in the study; posttraumatic stressdisorder, major depressive disorder (MDD) with psychotic features, borderline orantisocial personality disorder
Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (otherthan nicotine or caffeine) within one (1) year prior to Screening.
Subject has received ketamine, esketamine, arketamine, or psychedelic therapies (eg,psilocybin, methylenedioxymethamphetamine [MDMA]) for MDD or any psychiatriccondition within one (1) year prior to Screening.
In the opinion of the Investigator: (a) study participation may pose a significantor undue risk to the subject; (b) the subject is unlikely to successfully completeall of the requirements of the study per protocol; or (c) study participation mayadversely impact the integrity of the data or the validity of the study results.
Study Design
Connect with a study center
CNS Healthcare
Orlando, Florida 32801
United StatesSite Not Available
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesSite Not Available
Curavit Clinical Research
Boston, Massachusetts 02116
United StatesSite Not Available
Midwest Research Group
Saint Charles, Missouri 63304
United StatesSite Not Available
Alivation Health, LLC
Lincoln, Nebraska 68526
United StatesSite Not Available
Cedar Clinical Research
Draper, Utah 84020
United StatesSite Not Available
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