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Recruiting NCT06399523

A Study to Evaluate the Efficacy of VR for Bipolar Disorder

Trial Parameters

Condition Bipolar Disorder
Sponsor Shanghai Mental Health Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 48
Sex ALL
Min Age 13 Years
Max Age N/A
Start Date 2024-03-04
Completion 2024-12-30
Interventions
VR therapyVR sham

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Poor physical condition unable to participate in the study * Currently or previously diagnosed with other major mental disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) * Severe or active physical illnesses that interfere with the study treatment * Suicidal or self-harming ideas (defined as a score of \>3 on item 3 of the Hamilton Depression Scale-17 suicide scale) * Pregnant or lactating women * Participate in other clinical trials within 1 month * Epilepsy or severe eye diseases

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