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Not Yet Recruiting NCT05701345

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

Conditions: Depressive Disorder, Major Depressive Disorder, Depressive Episode

Sex: All
Ages: 19 Years – 64 Years
Phase: PHASE3
Enrollment: 162
Sponsor: Omni C&S

Location: Korea, Republic of

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.

Eligibility Criteria

Inclusion Criteria:right-handed men and womenIf you agree to participate in this clinical trial and voluntarily sign a written consent formIf you can understand and cooperate with the contents of this clinical trialIf you have a wireless internet(Wifi) environmentDiagnosed 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 disorderMild or moderate depressive episodes with a total hdrs score of 7 or more and 24 or lessIf there was no change in the type and dose of antidepressants and antipsychotics taken within 4 weeks prior to participation in this clinical trialExclusion Criteria:if you are pregnantSchizophrenia, schizoaffective disorder, schizophrenic disorder, or a psychotic disorder not otherwise classified or diagnosed in the pastIf you have current bipolar disorder or have been diagnosed with bipolar disorder in your past historyAccompanied by organic mental disorder, epilepsy/convulsive disorderCurrent eating disorders, alcohol and other substance-related disorders, and obsessive-compulsive disorderUncontrolled and unstable clinically significant physical conditionIn cases where psychiatric evaluation and maintenance of treatment are difficult due to other serious acute physical illnessesIf you have received electroconvulsive therapy and transcranial magnetic stimulation therapy for a current depressive episodeTreatment-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 episodeCurrently 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 directorCurrent depressive episode accompanied by psychotic symptomsCases in which a therapeutic intervention for a clinical trial cannot be performed due to deterioration of eyesight or hearingCurrent treatment with mood stabilizers (lithium, valproate, carbamazepine, lamotrigine) for depressive episodesThose who are unable to participate in clinical trials due to the judgment of other researchersThose who cannot read the consent form (ex. illiterate, foreigners)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05701345). StuddyBuddy aggregates publicly available trial information.