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

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).

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder (SAD)
• Intervention / Treatment: Device: BVR-100; Device: BES-100

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trial Disclosure; Phone Number: 1-866-503-6351; Email: clinicaltrialdisclosure@sunovion.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BVR-100; Experimental at-home VR intervention for the treatment of SAD	Device: BVR-100; Experimental self-guided VR intervention for the treatment of SAD
Active Comparator: BES-100; Active at-home VR intervention comparator	Device: BES-100; Active at-home VR intervention comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The measurement of intervention credibility and expectancy of benefit, assessed with the Credibility / Expectancy Questionnaire (CEQ) scores	baseline, week 6, week 8 (EOS)

Secondary Outcome Measures

Outcome Measure	Time Frame
subject retention of BVR-100 and BES-100	week 6, week 8 (EOS)
time-on-task of BVR-100 and BES-100	week 6, week 8 (EOS)

Collaborators and Investigators

• Sponsor: Sumitomo Pharma America, Inc.
• Collaborators: BehaVR LLC
• Investigators: Study Director: Robert Hayes, PhD, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Social Anxiety Disorder, Social Phobia
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: BVR-100-102

Drug and device information, study documents

• 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