Prospective, Multicenter, Assessor-blind, Randomized, Comparative, Pivotal Study to Evaluate the Efficacy and Safety of Wearable Visual Device (HMD)-VR-based Software Medical Device(OMNIFIT DTx-MDD) for Patients with Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Comparison of change in Hamilton Depression Rating Scale total score
研究概览
简要总结
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.
详细描述
Trial subject is a mild and moderate patients diagnosed with depressive disorder The test group is a wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD) and patients who have received standard treatment.
The number of subjects is 162(Two groups, 81 people per group, 15% dropout rate included) Participating institutions are five including Catholic University of Korea Seoul ST.
The clinical trial method is as follows. Subjects who are satisfied with all selection/exclusion criteria and agree to participate in clinical trials are classified into groups that combine test software medical devices and standard treatment based on Visit 2 (Baseline) and groups that perform simple standard treatment. After that, necessary tests are performed at 2, 4, 6, and 8 weeks, and changes in depressive disorder and depressive disorder evaluation scale are confirmed, and safety is evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Those who cannot read the consent form (ex. illiterate, foreigners)
研究组 & 干预措施
medical device used group
Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)
干预措施: OMNIFIT DTx-MDD (Device)
medical device used group
Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD)
干预措施: standard treatment (Other)
medical device unused group
Patients receiving only standard treatment
干预措施: standard treatment (Other)
结局指标
主要结局
Comparison of change in Hamilton Depression Rating Scale total score
时间窗: 8 weeks
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.
次要结局
- Comparison of dropout rates(8 weeks)
- Comparison of Changes in Patient Health Questionnaire-9 Scores(8 weeks)
- Comparison of side effects(8 weeks)
- Comparison of response rate and remission rate by Hamilton Depression Rating Scale(8 weeks)
- Comparison of adverse events(8 weeks)
- Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression(8 weeks)