Status:
COMPLETED
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
Lead Sponsor:
Sumitomo Pharma America, Inc.
Collaborating Sponsors:
BehaVR LLC
Conditions:
Social Anxiety Disorder (SAD)
Eligibility:
All Genders
18-99 years
Phase:
NA
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06037668
Start Date
September 8 2023
End Date
January 10 2024
Last Update
March 12 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
CNS Healthcare
Orlando, Florida, United States, 32801
2
Curavit Clinical Research
Boston, Massachusetts, United States, 02116
3
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
4
Midwest Research Group
Saint Charles, Missouri, United States, 63304