| Eligibility |
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, Fifth
Edition, (DSM-5) criteria for Social Anxiety Disorder
- Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of = 70.
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 nausea or
dizziness.
- Subject has injuries, inflammation or infection affecting the eyes, ears or face that
would make the use of the hardware uncomfortable.
- Subject has, current or lifetime history of meeting DSM-5 criteria for schizophrenia
spectrum or other psychotic disorder, bipolar or related disorder, major
neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or
of a severity that impacts the subject's ability to consent, follow study directions,
or otherwise safely participate in the study; posttraumatic stress disorder, major
depressive disorder (MDD) with psychotic features, borderline or antisocial
personality disorder
- Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (other than
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 psychiatric condition
within one (1) year prior to Screening.
- In the opinion of the Investigator: (a) study participation may pose a significant or
undue risk to the subject; (b) the subject is unlikely to successfully complete all of
the requirements of the study per protocol; or (c) study participation may adversely
impact the integrity of the data or the validity of the study results.
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