Depressive DisorderNCT05701345
Study of Virtual Reality-based Medical Device for Patients with Depressive Disorder
A study testing OMNIFIT DTx-MDD and standard treatment in people with Depressive Disorder and Major Depressive Disorder, run by Omni C&S at 5 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Depressive Disorder, Major Depressive Disorder, Depressive Episode
- What is being tested?
- OMNIFIT DTx-MDD and standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 9 Mar 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Inje University Ilsan Palk Hospital
Ilsan
Jeju National University Hospital
Jeju City
Seoul ST. Mary's Hospital
Seoul
Yeouido ST. Mary's Hospital
Seoul
ST. Vincent's Hospital
Suwon
About this study
Official title: 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
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.
Read the 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.
- Being tested
- OMNIFIT DTx-MDD, standard treatment
- Keywords
- mild and moderate depressive disorder
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNIFIT DTx-MDDDevice
Also called Wearable visual device-based software medical 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
standard treatmentOther
Also called Antidepressant
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.
| Study group | Role | What they receive |
|---|---|---|
| medical device used group | Experimental | Wearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD) Receives: Device: OMNIFIT DTx-MDD; Other: standard treatment |
| medical device unused group | Placebo comparator | Patients receiving only standard treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
Comparison of response rate and remission rate by Hamilton Depression Rating Scale
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.
Measured: 8 weeks
Comparison of Changes in Patient Health Questionnaire-9 Scores
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.
Measured: 8 weeks
Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression
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.
Measured: 8 weeks
Comparison of side effects
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.
Measured: 8 weeks
Comparison of adverse events
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.
Measured: 8 weeks
Comparison of dropout rates
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start9 Mar 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multiple-Group Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omni C&S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Youngsup Woo, Principal investigator, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701345
- Sponsor's protocol ID
- OMNI_MDD_01
- Status last verified
- Nov 2024
- First submitted
- 12 Jan 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05701345
- Acronym / sponsor ID
- OMNI_MDD_01
- Keywords
- mild and moderate depressive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Omni C&SIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multiple-Group Assignment
| Arm | Type | Receives |
|---|---|---|
| medical device used group | Experimental | Device: OMNIFIT DTx-MDD, Other: standard treatmentWearable visual device(HMD)-VR-based software medical device(OMNIFIT DTx-MDD) |
| medical device unused group | Placebo comparator | Other: standard treatmentPatients receiving only standard treatment |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNIFIT DTx-MDDAlso: Wearable visual device-based software medical deviceThis 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 | Device | medical device used group |
| standard treatmentAlso: AntidepressantIt 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. | Other | medical device unused group, medical device used group |
Primary outcome
Comparison of change in Hamilton Depression Rating Scale total score
Time frame: 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.
6 secondary outcomes
Comparison of response rate and remission rate by Hamilton Depression Rating Scale
Time frame: 8 weeks
Comparison of Changes in Patient Health Questionnaire-9 Scores
Time frame: 8 weeks
Comparison of Changes in Clinical Global Impression - Severity & Clinical Global Impression
Time frame: 8 weeks
Comparison of side effects
Time frame: 8 weeks
Comparison of adverse events
Time frame: 8 weeks
Comparison of dropout rates
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngsup Woo principal investigator
Yeouido St. Mary's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNIFIT DTx-MDD and standard treatment in people with Depressive Disorder and Major Depressive Disorder, run by Omni C&S at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in Hamilton Depression Rating Scale total score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.