A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
Completed · Not applicable
Conditions studied: Social Anxiety Disorder (SAD)
In brief
This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).
Key facts
- Study ID
- NCT06037668
- Run by
- Sumitomo Pharma America, Inc.
- People needed
- 56
- Starts
- 2023-09-08
- Expected to finish
- 2024-01-10
- Last updated by the study team
- 2025-03-12
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- CNS Healthcare — Orlando, Florida, United States
- Curavit Clinical Research — Boston, Massachusetts, United States
- Boston Clinical Trials — Boston, Massachusetts, United States
- Midwest Research Group — Saint Charles, Missouri, United States
- Alivation Health, LLC — Lincoln, Nebraska, United States
- Cedar Clinical Research — Draper, Utah, United States
Full record on ClinicalTrials.gov
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