Depression D003863
Conditions
Interventions
Subjects will receive neurofeedback training by visual stimulation using a software program on a PC or tablet (monitor) with reference to EEG data acquired with a portable electroencephalograph (EEG)
Neurofeedback
Sponsors
Oribe Naoya
Okuda Kazutaka
Universal Brain, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (at least 18 years old at the time consent is obtained) 2. Major depressive episode as defined by the diagnostic criteria of the DSM 5 3. One of the following a. Hamilton Depression Rating Score (HDRS 17) of 19 or higher b. Montgomery Asberg Depression Rating Scale score of 20 or higher c. Any other patient deemed appropriate by the PI (subprincipal investigator) 4. With respect to taking antidepressants, any of the following a. not taking antidepressants b. If taking antidepressants, willingness to continue them for the duration of the program. 5. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation 6. Have treated by a psychiatrist 7. Written informed consent 8. No planned change in employment status after the study begins
Exclusion criteria
Exclusion criteria: 1. High risk of suicide, such as suicidal ideation or suicide attempts 2. History of hospitalization for depression or suicidal behavior 3. Comorbid addictions (drugs, alcohol) or history of addictions 4. Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease) 5. History of seizures or epilepsy 6. Has a serious or unstable physical disease 7. Difficulty or inappropriateness/contraindication to MRI imaging 8. Pregnant women or unwilling to practice contraception during the study 9. Participating in another clinical trial at the same time, or have participated in a clinical trial within the past 90 days, or are scheduled to participate in another clinical trial during the study period, and the principal (sub)investigator determines that participation in another clinical trial may interfere with the results of this study 10. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD21 score at 4 weeks compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. compared to baseline a. HAMD21 scores at 2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention b. MADRS scores at 2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention c. SDS scores at 2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention d. HAMD21 score at the end of the intervention e. MADRS score at the end of the intervention 2. HAMD21 response rate (>=50% reduction) and remission rate (<=7 points) at 8 weeks post-intervention 3. duration of remission if remission occurred after the end of the intervention Quality of life assessment (EQ-5D-3L) at 2 and 4 weeks after the start of the intervention and at 4, 12 and 24 weeks after the end of the intervention PHQ-9 score at 2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention 6. changes in brain activity at 2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention | — |
Contacts
Public ContactHiroaki Harashima
UNB Sumiyoshi Jinja Mae Clinic
Outcome results
None listed