A Randomized, Double-Blind, Sponsor-Initiated Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Mindchair in Patient with Major Depressive Disorder

A Randomized, Double-Blind, Sponsor-Initiated Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Mindchair in Patient with Major Depressive Disorder (MDD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0012154

Enrollment

Registered

2026-06-22

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The intervention will be conducted over 4 weeks, with participants attending four visits at baseline, week 1, week 2, and week 4. At each visit, the assigned device will be applied tw

however, the sham device will provide the same degraded virtual reality video content without real-time physiological biofeedback. Thus, the key difference between groups is the presence or absence of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria: ? Individuals diagnosed with Major Depressive Disorder according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, confirmed through the Mini-International Neuropsychiatric Interview (MINI). ? Individuals with a Patient Health Questionnaire-9 score = 10. ? Adults aged 20 years or older.

Exclusion criteria

Exclusion criteria: Participants must not meet any of the following criteria: ? Individuals diagnosed, according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, with psychiatric disorders such as Schizophrenia, Bipolar Disorder, Post-Traumatic Stress Disorder, or Obsessive-Compulsive Disorder. However, Depressive Disorder, Sleep Disorder, and Anxiety Disorder are permitted. ? Individuals with medically unstable major illnesses. However, Diabetes Mellitus and Hypertension are permitted if the type and dosage of medication have remained stable for at least 3 months. ? Individuals currently receiving treatment for dizziness or vestibular disorders, such as Benign Paroxysmal Positional Vertigo or Ménière's Disease. ? Individuals who have taken mood stabilizers or anti-dementia medications within 1 month prior to screening. ? Individuals with a history of hepatic or renal dysfunction prior to screening. ? Individuals deemed unsuitable for participation by the principal investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Change in the total score of the Beck Depression Inventory-II from baseline to Week 4	—

Secondary

Measure	Time frame
Change in the score of the Patient Health Questionnaire-9;Change in the score of the Panic Disorder Severity Scale;Change in the score of the Generalized Anxiety Disorder-7;Change in the score of the Pittsburgh Sleep Quality Index;Change in the score of the Simulator Sickness Questionnaire;Change in the score of the Igroup Presence Questionnaire;Change in the treatment satisfaction assessment score	—

Measure

Time frame

Change in the score of the Patient Health Questionnaire-9;Change in the score of the Panic Disorder Severity Scale;Change in the score of the Generalized Anxiety Disorder-7;Change in the score of the Pittsburgh Sleep Quality Index;Change in the score of the Simulator Sickness Questionnaire;Change in the score of the Igroup Presence Questionnaire;Change in the treatment satisfaction assessment score

—

Countries

Korea, Republic of

Contacts

Public ContactYoojin Jang

Samsung Medical Center

yjjjs519@naver.com+82-2-3410-3588

Outcome results