Social Anxiety Disorder (SAD)BVR-100-102NCT06037668

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

A study testing BVR-100 and BES-100 in people with Social Anxiety Disorder (SAD), run by Sumitomo Pharma America, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Social Anxiety Disorder (SAD)
What is being tested?: BVR-100 and BES-100
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 6 sitesUnited States
Study dates: 8 Sep 2023to 10 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Curavit Clinical Research
Boston, Massachusetts, 02116
Boston Clinical Trials
Boston, Massachusetts, 02131
Cedar Clinical Research
Draper, Utah, 84020
Alivation Health, LLC
Lincoln, Nebraska, 68526
CNS Healthcare
Orlando, Florida, 32801
Midwest Research Group
Saint Charles, Missouri, 63304

Other trials in United States

About this study

Official title: BVR-100 and BES-100 Validation Trial: A Randomized, Double-Blind, Parallel-Group, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.

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

Conditions: Social Anxiety Disorder (SAD)
Being tested: BVR-100, BES-100
Keywords: Social Anxiety Disorder, Social Phobia
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BVR-100Device
Experimental self-guided VR intervention for the treatment of SAD
BES-100Device
Active at-home VR intervention comparator

Study groups in NCT06037668
Study group	Role	What they receive
BVR-100	Experimental	Experimental at-home VR intervention for the treatment of SAD Receives: Device: BVR-100
BES-100	Active comparator	Active at-home VR intervention comparator Receives: Device: BES-100

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of Intervention Credibility Assessed With the Credibility Score, at 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.
Measured: Baseline
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6
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.
Measured: 6 weeks
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8
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.
Measured: 8 weeks
Measurement of Intervention Credibility Assessed With Expectancy Score, at 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.
Measured: Baseline
Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6
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.
Measured: 6 weeks
Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8
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.
Measured: 8 weeks

Secondary outcomes (3)

Subject Retention Rate at Week 6
Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6
Measured: 6 weeks
Subject Retention Rate at Week 8
Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8
Measured: 8 weeks
Summary of Time-on-Task
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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202310 Jan 2024

First posted14 Sep 2023
Study start8 Sep 2023
Primary completion22 Dec 2023
Study completion10 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06037668
Sponsor's protocol ID: BVR-100-102
Acronym: BVR-100-102
Status last verified: Feb 2025
First submitted: 7 Sep 2023
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
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Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
Social Anxiety Disorder (SAD)
Recruiting
Efficacy of Expectancy Focused Exposure Therapy for Anxiety Disorders
Anxiety Disorders, Panic Disorder
RecruitingPhase 2
A Study of NTX-1472 in Social Anxiety Disorder
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Recruiting
Efficacy of Attention Bias Modification vs. Placebo for Social Anxiety Disorder
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All Social Anxiety Disorder (SAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BVR-100 and BES-100 Validation Trial: A Randomized, Double-Blind, Parallel-Group, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
ClinicalTrials.gov ID: NCT06037668
Acronym / sponsor ID: BVR-100-102 / BVR-100-102
Conditions: Social Anxiety Disorder (SAD)
Keywords: Social Anxiety Disorder, Social Phobia
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Collaborators: BehaVR LLC
Study start: 8 Sep 2023 (actual)
Primary completion: 22 Dec 2023 (actual)
Study completion: 10 Jan 2024 (actual)
First posted: 14 Sep 2023 (actual)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BVR-100	Experimental	Device: BVR-100Experimental at-home VR intervention for the treatment of SAD
BES-100	Active comparator	Device: BES-100Active at-home VR intervention comparator

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BVR-100Experimental self-guided VR intervention for the treatment of SAD	Device	BVR-100
BES-100Active at-home VR intervention comparator	Device	BES-100

Primary outcome

Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline
Time frame: 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.
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6
Time frame: 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.
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8
Time frame: 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.
Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline
Time frame: 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.
Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6
Time frame: 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.
Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8
Time frame: 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.

3 secondary outcomes

Subject Retention Rate at Week 6
Time frame: 6 weeks
Subject Retention Rate at Week 8
Time frame: 8 weeks
Summary of Time-on-Task
Time frame: 8 weeks

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BVR-100	28	24
BES-100	28	27

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

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	BVR-100 n = 18	BES-100 n = 14
Value	18 (4.31)	15.4 (4.57)

BVR-100 vs BES-100: p = 0.1134, Independent t-test

Population analysed: ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline

Primary outcome: Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	BVR-100 n = 17	BES-100 n = 17
Value	18.9 (5.37)	12.3 (6.56)

BVR-100 vs BES-100: p = 0.003100, Independent t-test

Population analysed: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6

Primary outcome: Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	BVR-100 n = 15	BES-100 n = 19
Value	18.7 (6.31)	13.7 (7.68)

BVR-100 vs BES-100: p = 0.050300, Independent t-test

Population analysed: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8

Primary outcome: Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	BVR-100 n = 18	BES-100 n = 14
Value	17.1 (4.43)	14.8 (3.24)

BVR-100 vs BES-100: p = 0.1178, Independent t-test

Population analysed: ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 8 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BVR-100	0 of 25 (0%)	3 of 25 (12%)	0 of 25
BES-100	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Social Anxiety Disorder (SAD)

RecruitingPhase 4
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
Social Anxiety Disorder (SAD)
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
Social Anxiety Disorder (SAD)
Recruiting
Efficacy of Expectancy Focused Exposure Therapy for Anxiety Disorders
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RecruitingPhase 2
A Study of NTX-1472 in Social Anxiety Disorder
Social Anxiety Disorder (SAD)
Recruiting
Efficacy of Attention Bias Modification vs. Placebo for Social Anxiety Disorder
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Hayes, PhD study director

Sumitomo Pharma America, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BVR-100 and BES-100 in people with Social Anxiety Disorder (SAD), run by Sumitomo Pharma America, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06037668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.