Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
NCT Number: NCT06557525
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Depression
Interventions: BEHAVIORAL: Neurofeedback
Sponsor: UNB Sumiyoshi Jinja Mae Clinic
Collaborators: Universal Brain, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-20
Completion Date: 2025-03-31
Locations: UNB Sumiyoshi Jinja Mae Clinic, Fukuoka, 812-0018, Japan

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).

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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