Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

UNB Sumiyoshi Jinja Mae Clinic

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Depression

Treatments

Behavioral: Neurofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT06557525

frontier

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Adults (at least 18 years old at the time consent is obtained)
1. Major depressive episode as defined by the diagnostic criteria of the DSM 5
1. One of the following
2. Hamilton Depression Rating Score (HDRS 17) of 19 or higher
3. Montgomery Asberg Depression Rating Scale score of 20 or higher
4. Any other patient deemed appropriate by the PI (subprincipal investigator)
1. With respect to taking antidepressants, any of the following
2. not taking antidepressants
3. If taking antidepressants, willingness to continue them for the duration of the program.
1. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation
1. Have treated by a psychiatrist
1. Written informed consent
1. No planned change in employment status after the study begins

Exclusion criteria

1. High risk of suicide, such as suicidal ideation or suicide attempts
1. History of hospitalization for depression or suicidal behavior
1. Comorbid addictions (drugs, alcohol) or history of addictions
1. Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease)
1. History of seizures or epilepsy
1. Has a serious or unstable physical disease
1. Difficulty or inappropriateness/contraindication to MRI imaging
1. Pregnant women or unwilling to practice contraception during the study
1. 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
1. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.