A Prospective, Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Bipolar disorder is characterized by high morbidity, recurrence, disability, suicide and comorbidity rate which need novel, efficient, and safe treatment methods, and VR has demonstrate its efficacy in mental disease but not few focus on bipolar disorder. A prospective single center randomize clinical study therefore would be carried on to evaluate the efficacy of VR for Bipolar Disorder in China.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:

• 13 years or older

• Meet the diagnostic criteria for bipolar disorder - depressive episode in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

• Able to understand the content of the scale

• Certain abilities in expressive, reading, and listening

• Total score of \>17 on the Hamilton Rating Scale for Depression (HAMD-17)

• Inform consent

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2025-03-04
Participants
Target number of participants: 48
Treatments
Experimental: VR therapy
Placebo_comparator: VR sham
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mental Health Center
Collaborators: Nanjing XR-Oasis Technology Co., Ltd.

This content was sourced from clinicaltrials.gov