N/A N=56 Randomized Triple-blind Treatment

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

Social Anxiety Disorder (SAD)

Bottom Line

View on ClinicalTrials.gov: NCT06037668 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline — 18; 15.4 units on a scale — p=0.1134

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BVR-100 (Device); BES-100 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sumitomo Pharma America, Inc.
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline	18; 15.4	0.1134
PRIMARY Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6	18.9; 12.3	0.003100 sig
PRIMARY Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8	18.7; 13.7	0.050300
PRIMARY Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline	17.1; 14.8	0.1178
PRIMARY Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6	15.4; 11.6	0.1003
PRIMARY Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8	15.3; 13.6	0.4832
SECONDARY Subject Retention Rate at Week 6	96; 100	—
SECONDARY Subject Retention Rate at Week 8	96; 100	—
SECONDARY Summary of Time-on-Task	4.97; 6.59	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06037668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.