A Study to Evaluate the Efficacy of VR for Bipolar Disorder

NCT06399523 | Recruiting

• 1 other identifier: YYLZ-CTP-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; VR; Interventional Study

Outcome Measures

Primary Outcomes (1)

• Evolution of Depression

  Changes in the total score of HAMD-17 at the end of the study compared to baseline

  1 month

Secondary Outcomes (10)

• Early Response

  2 weeks

• Clinical Response

  2 months

• Clinical Remission

  2 months

• Changes in the Clinical Global Impression Scale

  2 months

• Conversion to mania

  2 months

Study Arms (2)

VR therapy

EXPERIMENTAL

Device: VR therapy

VR sham

PLACEBO COMPARATOR

Device: VR sham

Interventions

VR therapy DEVICE

Participants this group received additional VR therapy , with a total 20 sessions over a period of 4 weeks based on routine treatment.

VR therapy

VR sham DEVICE

Participants in this group received additional VR sham(health education videos,a total of 20 health education videos over a period of 4 weeks) under virtual reality conditions on the basis of routine treatment.

VR sham

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Nanjing XR-Oasis Technology Co., Ltd.: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 3, 2024
• Study Start: March 4, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 4, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)