Clinical trial NCT06557525: Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
Official title: Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Depression
Lead sponsor: UNB Sumiyoshi Jinja Mae Clinic
Sponsor class: OTHER
Collaborators: name: Universal Brain, LLC
First posted: 2024-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

  1. Hamilton Depression Rating Score (HDRS 17) of 19 or higher
  2. Montgomery Asberg Depression Rating Scale score of 20 or higher
  3. Any other patient deemed appropriate by the PI (subprincipal investigator)
* 4. With respect to taking antidepressants, any of the following

  1. not taking antidepressants
  2. If taking antidepressants, willingness to continue them for the duration of the program.
* 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:

* 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.

Primary outcomes:
measure: HAMD21 change after intervention
timeFrame: 4 weeks after the start of the intervention
Secondary outcomes:
measure: HAMD21 compared to baseline
timeFrame: 2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention
measure: MADRS compared to baseline
timeFrame: 2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention
measure: SDS compared to baseline
timeFrame: 2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention
measure: HAMD21 after intervention
timeFrame: 4 weeks after the start of the intervention
measure: MADRS after intervention
timeFrame: 4 weeks after the start of the intervention
measure: HAMD21 response rate
timeFrame: 8 weeks after the start of the intervention
measure: HAMD21 remission rate
timeFrame: 8 weeks after the start of the intervention
measure: duration of remission after the end of the intervention
timeFrame: up to 24 weeks after the end of the intervention
measure: Quality of life assessment (EQ-5D-3L)
timeFrame: 2 and 4 weeks after the start of the intervention and at 4, 12 and 24 weeks after the end of the intervention
measure: PHQ-9 score
timeFrame: 2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention
measure: changes in brain activity
timeFrame: 2 and 4 weeks after the start of the intervention
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: UNB Sumiyoshi Jinja Mae Clinic
Study officials:
References: