Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

JRCT ID: jRCTs032230463

Registered date:20/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Depression
• Date of first enrollment: 20/11/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: HAMD21 score at 4 weeks compared to baseline

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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. In the 6 weeks prior to enrollment, any of the following
a. not taking antidepressants
b.Stable antidepressant medication and agrees to remain on the same medication during study
5. With stable psychotherapy for at least 6 weeks prior to enrollment and agrees to continue the same psychotherapy for the duration of study
6. Have treated by a psychiatrist
7. Written informed consent
8. No planned change in employment status after the study begins

Exclude 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.

Related Information

• Primary Sponsor: Oribe Naoya
• Secondary Sponsor: Okuda Kazutaka,Universal Brain, LLC