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| Name | Class |
|---|---|
| Universal Brain, LLC | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HAMD21 change after intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline. | 4 weeks after the start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| HAMD21 compared to baseline | HAMD21(Hamilton Depression Rating Scale, 21-item version) score 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 compared to baseline |
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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
4. With respect to taking antidepressants, any of the following
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroaki Harashima | Contact | 092-477-1101 | study@unbclinic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNB Sumiyoshi Jinja Mae Clinic | Recruiting | Fukuoka | 812-0018 | Japan |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
MADRS(Montgomery Åsberg Depression Rating Scale) score 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 compared to baseline | SDS(Self-rating Depression Scale) score 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 after intervention | HAMD21(Hamilton Depression Rating Scale, 21-item version) score | 4 weeks after the start of the intervention |
| MADRS after intervention | MADRS(Montgomery Åsberg Depression Rating Scale) score | 4 weeks after the start of the intervention |
| HAMD21 response rate | HAMD21(Hamilton Depression Rating Scale, 21-item version) response rate (>=50% reduction) | 8 weeks after the start of the intervention |
| HAMD21 remission rate | HAMD21(Hamilton Depression Rating Scale, 21-item version) remission rate (<=7 points) | 8 weeks after the start of the intervention |
| duration of remission 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) | up to 24 weeks after the end of the intervention |
| Quality of life assessment (EQ-5D-3L) | Quality of life assessment (EQ-5D-3L(EuroQol 5 dimensions 3-level)) | 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 | PHQ-9(Patient Health Questionnaire-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 |
| changes in brain activity | EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain | 2 and 4 weeks after the start of the intervention |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |