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NCT06037668: BVR-100-102

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

Completed NA Results posted Last updated 12 March 2025
What this trial tests

NA trial testing BVR-100 in Social Anxiety Disorder (SAD) in 56 participants. Completed in 10 January 2024.

Timeline
8 September 2023
Primary endpoint
22 December 2023
10 January 2024

Quick facts

Lead sponsorSumitomo Pharma America, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment56
Start date8 September 2023
Primary completion22 December 2023
Estimated completion10 January 2024
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sumitomo Pharma America, Inc. — full company profile →

Who can join

Adults 18 to 99, any sex, with Social Anxiety Disorder (SAD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline Primary · Baseline

The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.

GroupValue95% CI
BVR-10018± 4.31
BES-10015.4± 4.57
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6 Primary · 6 weeks

The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.

GroupValue95% CI
BVR-10018.9± 5.37
BES-10012.3± 6.56
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8 Primary · 8 weeks

The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.

GroupValue95% CI
BVR-10018.7± 6.31
BES-10013.7± 7.68
Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline Primary · Baseline

The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.

GroupValue95% CI
BVR-10017.1± 4.43
BES-10014.8± 3.24
Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6 Primary · 6 weeks

The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.

GroupValue95% CI
BVR-10015.4± 5.75
BES-10011.6± 7.14
Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8 Primary · 8 weeks

The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.

GroupValue95% CI
BVR-10015.3± 6.21
BES-10013.6± 7.47
Subject Retention Rate at Week 6 Secondary · 6 weeks

Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6

GroupValue95% CI
BVR-10096
BES-100100
Subject Retention Rate at Week 8 Secondary · 8 weeks

Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8

GroupValue95% CI
BVR-10096
BES-100100
Summary of Time-on-Task Secondary · 8 weeks

Time-on-task, averaged over all VR sessions from baseline to Week 8/EOS. Time on task will be automatically recorded by the VR system after each session.

GroupValue95% CI
BVR-1004.97± 1.886
BES-1006.59± 0.359

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 8 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BVR-100
Serious: 0/25 (0%)
Deaths: 0/25
BES-100
Serious: 0/27 (0%)
Deaths: 0/27
Other adverse events (2 terms — click to expand)

ReactionSystemBVR-100BES-100
COVID-19Infections and infestations
DizzinessNervous system disorders

Data from ClinicalTrials.gov NCT06037668 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. CNS Summit 2024: Abstracts of Poster Presentations
    · 2024

Verify or expand the search:

Other recruiting trials for Social Anxiety Disorder (SAD)

Currently open trials in the same condition.

Other Sumitomo Pharma America, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06037668.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing