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

Last updated: February 20, 2025
Sponsor: Sumitomo Pharma America, Inc.
Overall Status: Completed

Phase

N/A

Condition

Social Anxiety Disorder (Sad)

Anxiety Disorders

Panic Disorders

Treatment

BVR-100

BES-100

Clinical Study ID

NCT06037668
BVR-100-102
  • Ages 18-99
  • All Genders

Study 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

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, FifthEdition, (DSM-5) criteria for Social Anxiety Disorder

  • Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥

Exclusion

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 nauseaor dizziness.

  • Subject has injuries, inflammation or infection affecting the eyes, ears or facethat would make the use of the hardware uncomfortable.

  • Subject has, current or lifetime history of meeting DSM-5 criteria for schizophreniaspectrum or other psychotic disorder, bipolar or related disorder, majorneurocognitive disorder, neurodevelopmental disorder of greater than mild severityor of a severity that impacts the subject's ability to consent, follow studydirections, or otherwise safely participate in the study; posttraumatic stressdisorder, major depressive disorder (MDD) with psychotic features, borderline orantisocial personality disorder

  • Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (otherthan 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 psychiatriccondition within one (1) year prior to Screening.

  • In the opinion of the Investigator: (a) study participation may pose a significantor undue risk to the subject; (b) the subject is unlikely to successfully completeall of the requirements of the study per protocol; or (c) study participation mayadversely impact the integrity of the data or the validity of the study results.

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: BVR-100
Phase:
Study Start date:
September 08, 2023
Estimated Completion Date:
January 10, 2024

Connect with a study center

  • CNS Healthcare

    Orlando, Florida 32801
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Curavit Clinical Research

    Boston, Massachusetts 02116
    United States

    Site Not Available

  • Midwest Research Group

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Alivation Health, LLC

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Cedar Clinical Research

    Draper, Utah 84020
    United States

    Site Not Available

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