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

Primary Purpose

Social Anxiety Disorder (SAD)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BVR-100
BES-100
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder (SAD) focused on measuring Social Anxiety Disorder, Social Phobia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Curavit Clinical ResearchRecruiting
  • Midwest Research GroupRecruiting
  • Cedar Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BVR-100

BES-100

Arm Description

Experimental at-home VR intervention for the treatment of SAD

Active at-home VR intervention comparator

Outcomes

Primary Outcome Measures

The measurement of intervention credibility and expectancy of benefit, assessed with the Credibility / Expectancy Questionnaire (CEQ) scores

Secondary Outcome Measures

subject retention of BVR-100 and BES-100
time-on-task of BVR-100 and BES-100

Full Information

First Posted
September 7, 2023
Last Updated
September 25, 2023
Sponsor
Sumitomo Pharma America, Inc.
Collaborators
BehaVR LLC
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1. Study Identification

Unique Protocol Identification Number
NCT06037668
Brief Title
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
Acronym
BVR-100-102
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
Collaborators
BehaVR LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder (SAD)
Keywords
Social Anxiety Disorder, Social Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BVR-100
Arm Type
Experimental
Arm Description
Experimental at-home VR intervention for the treatment of SAD
Arm Title
BES-100
Arm Type
Active Comparator
Arm Description
Active at-home VR intervention comparator
Intervention Type
Device
Intervention Name(s)
BVR-100
Intervention Description
Experimental self-guided VR intervention for the treatment of SAD
Intervention Type
Device
Intervention Name(s)
BES-100
Intervention Description
Active at-home VR intervention comparator
Primary Outcome Measure Information:
Title
The measurement of intervention credibility and expectancy of benefit, assessed with the Credibility / Expectancy Questionnaire (CEQ) scores
Time Frame
baseline, week 6, week 8 (EOS)
Secondary Outcome Measure Information:
Title
subject retention of BVR-100 and BES-100
Time Frame
week 6, week 8 (EOS)
Title
time-on-task of BVR-100 and BES-100
Time Frame
week 6, week 8 (EOS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure
Phone
1-866-503-6351
Email
clinicaltrialdisclosure@sunovion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hayes, PhD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Curavit Clinical Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
917-885-0024
First Name & Middle Initial & Last Name & Degree
Irina Angel, MD
Facility Name
Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
636-946-8032
First Name & Middle Initial & Last Name & Degree
Gregory Mattingly, MD
Facility Name
Cedar Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
801-369-4219
First Name & Middle Initial & Last Name & Degree
Reid J Robison, MD

12. IPD Sharing Statement

Learn more about this trial

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

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