Depression
Conditions
Brief summary
This is an exploratory study to test the efficacy of a novel EEG neurofeedback method in depressed patients. The investigators will measure the change in depressive symptoms before and after the intervention of the novel EEG neurofeedback method using the Depression Rating Scale (primary endpoint). In addition, The investigators will measure the changes in brain activity before and after the intervention using fMRI, and compare the changes in depressive symptoms over the treatment period (secondary endpoint).
Interventions
BEHAVIORALNeurofeedback
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) to provide feedback on the state of the DLPFC in the brain. The DLPFC status of the subject's brain is then fed back to the subject to continue stimulating the subject's reward system. Before and after these neurofeedback training sessions, fMRI imaging will be performed to confirm changes in brain activity.
Sponsors
Universal Brain, LLC
UNB Sumiyoshi Jinja Mae Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. Hamilton Depression Rating Score (HDRS 17) of 19 or higher 2. Montgomery Asberg Depression Rating Scale score of 20 or higher 3. Any other patient deemed appropriate by the PI (subprincipal investigator) * 4\. With respect to taking antidepressants, any of the following 1. not taking antidepressants 2. 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
* 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 | Description |
|---|---|---|
| HAMD21 change after intervention | 4 weeks after the start of the intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS compared to baseline | 2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention | MADRS(Montgomery Åsberg Depression Rating Scale) score compared to baseline. |
| SDS compared to baseline | 2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention | SDS(Self-rating Depression Scale) score compared to baseline. |
| HAMD21 after intervention | 4 weeks after the start of the intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) score |
| MADRS after intervention | 4 weeks after the start of the intervention | MADRS(Montgomery Åsberg Depression Rating Scale) score |
| HAMD21 response rate | 8 weeks after the start of the intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) response rate (\>=50% reduction) |
| HAMD21 compared to baseline | 2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) score compared to baseline. |
| duration of remission after the end of the intervention | up to 24 weeks after the end of the intervention | duration of remission if remission occurred after the end of the intervention in HAMD21(Hamilton Depression Rating Scale, 21-item version) |
| Quality of life assessment (EQ-5D-3L) | 2 and 4 weeks after the start of the intervention and at 4, 12 and 24 weeks after the end of the intervention | Quality of life assessment (EQ-5D-3L(EuroQol 5 dimensions 3-level)) |
| PHQ-9 score | 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(Patient Health Questionnaire-9) score |
| changes in brain activity | 2 and 4 weeks after the start of the intervention | EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain |
| HAMD21 remission rate | 8 weeks after the start of the intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) remission rate (\<=7 points) |
Countries
Japan
Contacts
Primary ContactHiroaki Harashima
Outcome results
None listed