A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder. (BVR-100-102)

Sumitomo Pharma

Status: Completed

Conditions: Social Anxiety Disorder (SAD)

Treatments: Device: BVR-100; Device: BES-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT06037668

BVR-100-102

Details and patient eligibility

About

This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).

Enrollment: 56 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

BVR-100

Experimental group

Description:

Experimental at-home VR intervention for the treatment of SAD

Treatment:

Device: BVR-100

BES-100

Active Comparator group

Description:

Active at-home VR intervention comparator

Treatment:

Device: BES-100