Depressive Disorder, Depressive Episode, Major Depressive Disorder
Conditions
Keywords
mild and moderate depressive disorder
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.
Detailed description
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.
Interventions
DEVICEOMNIFIT DTx-MDD
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
OTHERstandard treatment
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.
Sponsors
Omni C&S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multiple-Group Assignment
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. right-handed men and women 2. If you agree to participate in this clinical trial and voluntarily sign a written consent form 3. If you can understand and cooperate with the contents of this clinical trial 4. If you have a wireless internet(Wifi) environment 5. 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 6. Mild or moderate depressive episodes with a total hdrs score of 7 or more and 24 or less 7. 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
Exclusion criteria
1. if you are pregnant 2. Schizophrenia, schizoaffective disorder, schizophrenic disorder, or a psychotic disorder not otherwise classified or diagnosed in the past 3. If you have current bipolar disorder or have been diagnosed with bipolar disorder in your past history 4. Accompanied by organic mental disorder, epilepsy/convulsive disorder 5. Current eating disorders, alcohol and other substance-related disorders, and obsessive-compulsive disorder 6. Uncontrolled and unstable clinically significant physical condition 7. In cases where psychiatric evaluation and maintenance of treatment are difficult due to other serious acute physical illnesses 8. If you have received electroconvulsive therapy and transcranial magnetic stimulation therapy for a current depressive episode 9. 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 10. Currently requiring inpatient treatment for a psychiatric disorder other than depressive disorder (ex. alcohol dependence, substance abuse) 11. If the risk of suicide, self-harm, or other harm is judged to be high according to the evaluation of the study director 12. Current depressive episode accompanied by psychotic symptoms 13. Cases in which a therapeutic intervention for a clinical trial cannot be performed due to deterioration of eyesight or hearing 14. Current treatment with mood stabilizers (lithium, valproate, carbamazepine, lamotrigine) for depressive episodes 15. Those who are unable to participate in clinical trials due to the judgment of other researchers 16. Those who cannot read the consent form (ex. illiterate, foreigners)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of change in Hamilton Depression Rating Scale total score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Changes in Patient Health Questionnaire-9 Scores | 8 weeks | The comparison of changes in the Patient Health Questionnaire-9 score between each group is performed by an independent two-sample student t-test, and the comparison within groups is evaluated by a paired-sample t-test. The Patient Health Questionnaire-9 score has a minimum value of 0 and a maximum value of 27 points, with higher scores indicating more severe depression. |
| Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression | 8 weeks | The comparison of changes in the Clinical Global Impression - Severity & Clinical Global Impression - Improvement scores between each group is performed by an independent two-sample student t-test, and the comparison within groups is evaluated by a paired-sample t-test. The Clinical Global Impression - Severity & Clinical Global Impression has a minimum value of 0 and a maximum value of 7 points, with higher scores indicating more severe depression. |
| Comparison of response rate and remission rate by Hamilton Depression Rating Scale | 8 weeks | chi-squared test or Fisher's exact test is performed to compare response rates (reduction of 50% or more from baseline) and remission rates (Hamilton Depression Rating Scale total score of 6 points or less) by Hamilton Depression Rating Scale between and within groups, and the within-group comparison is based on the frequency of improvement. Evaluate by performing McNemar test for The minimum value is 0 points and the maximum value is 52 points, with higher scores indicating more severe depressive symptoms. |
| Comparison of adverse events | 8 weeks | Comparison of side adverse events each group is evaluated by performing a chi-squared test or Fisher's exact test after using the test software medical device. |
| Comparison of dropout rates | 8 weeks | Comparison of dropout rates events each group is evaluated by performing a chi-squared test or Fisher's exact test after using the test software medical device. |
| Comparison of side effects | 8 weeks | Comparison of side effects between each group is evaluated by performing a chi-squared test or Fisher's exact test after using the test software medical device. |
Countries
South Korea
Outcome results
None listed