Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

UNB Sumiyoshi Jinja Mae Clinic1 site in 1 country30 target enrollmentNovember 20, 2023

ConditionsDepression

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Depression
Sponsor: UNB Sumiyoshi Jinja Mae Clinic
Enrollment: 30
Locations: 1
Primary Endpoint: HAMD21 change after intervention
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 20, 2023

End Date

March 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UNB Sumiyoshi Jinja Mae Clinic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults (at least 18 years old at the time consent is obtained)
•Major depressive episode as defined by the diagnostic criteria of the DSM 5
•One of the following
•Hamilton Depression Rating Score (HDRS 17) of 19 or higher
•Montgomery Asberg Depression Rating Scale score of 20 or higher
•Any other patient deemed appropriate by the PI (subprincipal investigator)
•With respect to taking antidepressants, any of the following
•not taking antidepressants
•If taking antidepressants, willingness to continue them for the duration of the program.
•If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation

Exclusion Criteria

•High risk of suicide, such as suicidal ideation or suicide attempts
•History of hospitalization for depression or suicidal behavior
•Comorbid addictions (drugs, alcohol) or history of addictions
•Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease)
•History of seizures or epilepsy
•Has a serious or unstable physical disease
•Difficulty or inappropriateness/contraindication to MRI imaging
•Pregnant women or unwilling to practice contraception during the study
•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
•Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.

Outcomes

Primary Outcomes

HAMD21 change after intervention

Time Frame: 4 weeks after the start of the intervention

HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline.

Secondary Outcomes

HAMD21 remission rate(8 weeks after the start of the intervention)
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)
changes in brain activity(2 and 4 weeks after the start of the intervention)
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)
HAMD21 response rate(8 weeks after the start of the intervention)
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)
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)
HAMD21 after intervention(4 weeks after the start of the intervention)
MADRS after intervention(4 weeks after the start of the intervention)
duration of remission after the end of the intervention(up to 24 weeks after the end of the intervention)
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)