Study of Virtual Reality-based Medical Device for Patients with Depressive Disorder

NCT05701345 | Completed

• 1 other identifier: OMNI_MDD_01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 5

Brief Summary

This study apply a wearable visual device (HMD)-VR-based software medical device for patients with depressive disorder for 8 weeks. The investigator would like to confirm evaluate the safety and efficacy of the wearable visual device(HMD)-VR-based software medical device effect of improving depressive disorder in patients.

Conditions

Depressive Disorder; Major Depressive Disorder; Depressive Episode

Keywords

mild and moderate depressive disorder

Outcome Measures

Primary Outcomes (1)

• Comparison of change in Hamilton Depression Rating Scale total score

  The comparison of changes in Hamilton Depression Rating Scale total score between each group is evaluated by Student t-test performing two independent samples. The minimum value is 0 points and the maximum value is 52 points, with higher scores indicating more severe depressive symptoms.

  8 weeks

Secondary Outcomes (6)

• Comparison of response rate and remission rate by Hamilton Depression Rating Scale

  8 weeks

• Comparison of Changes in Patient Health Questionnaire-9 Scores

  8 weeks

• Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression

  8 weeks

• Comparison of side effects

  8 weeks

• Comparison of adverse events

  8 weeks

Study Arms (2)

medical device used group

EXPERIMENTAL

Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)

Device: OMNIFIT DTx-MDD; Other: standard treatment

medical device unused group

PLACEBO COMPARATOR

Patients receiving only standard treatment

Other: standard treatment

Interventions

OMNIFIT DTx-MDD DEVICE

This software medical device consists of multifaceted interventions (breathing training, cognitive rehabilitation training, binaural beat training, concentration training) that help improve depressive disorder, and is automatically executed for 35 minutes per session

Also known as: Wearable visual device-based software medical device

medical device used group

standard treatment OTHER

It is based on the Korean Medical Association's clinical treatment guidelines for depression or the Korean Medical Association's Korean Medical Association/Korean Depression Management Association's 2021 guidelines for drug treatment for depression disorders. Standard treatment will be performed according to the judgment of the attending physician reflecting the clinical situation based on these treatment guidelines.

Also known as: Antidepressant

medical device unused group; medical device used group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• right-handed men and women
• If you agree to participate in this clinical trial and voluntarily sign a written consent form
• If you can understand and cooperate with the contents of this clinical trial
• If you have a wireless internet(Wifi) environment
• Diagnosed by a psychiatrist as major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorder 5th edition(DSM-5) or other specified depressive disorder
• Mild or moderate depressive episodes with a total hdrs score of 7 or more and 24 or less
• If there was no change in the type and dose of antidepressants and antipsychotics taken within 4 weeks prior to participation in this clinical trial

You may not qualify if:

• if you are pregnant
• Schizophrenia, schizoaffective disorder, schizophrenic disorder, or a psychotic disorder not otherwise classified or diagnosed in the past
• If you have current bipolar disorder or have been diagnosed with bipolar disorder in your past history
• Accompanied by organic mental disorder, epilepsy/convulsive disorder
• Current eating disorders, alcohol and other substance-related disorders, and obsessive-compulsive disorder
• Uncontrolled and unstable clinically significant physical condition
• In cases where psychiatric evaluation and maintenance of treatment are difficult due to other serious acute physical illnesses
• If you have received electroconvulsive therapy and transcranial magnetic stimulation therapy for a current depressive episode
• Treatment-resistant depressive disorder for which there was no effect even after using two or more antidepressants in sufficient doses and for a sufficient period of time (6 weeks) for the current depressive episode
• Currently requiring inpatient treatment for a psychiatric disorder other than depressive disorder (ex. alcohol dependence, substance abuse)
• If the risk of suicide, self-harm, or other harm is judged to be high according to the evaluation of the study director
• Current depressive episode accompanied by psychotic symptoms
• Cases in which a therapeutic intervention for a clinical trial cannot be performed due to deterioration of eyesight or hearing
• Current treatment with mood stabilizers (lithium, valproate, carbamazepine, lamotrigine) for depressive episodes
• Those who are unable to participate in clinical trials due to the judgment of other researchers

Sponsors & Collaborators

• Omni C&S: lead

Study Sites (5)

Inje University Ilsan Palk Hospital

Ilsan, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Seoul ST. Mary's Hospital

Seoul, South Korea

Location

Yeouido ST. Mary's Hospital

Seoul, South Korea

Location

ST. Vincent's Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Lymphoma, Follicular

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Youngsup Woo

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple-Group Assignment

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 27, 2023
• Study Start: March 9, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

KR (5)