Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

Phase 1

Recruiting

• Conditions: Depression
• Interventions: Behavioral: Neurofeedback

• Registration Number: NCT06557525
• Lead Sponsor: UNB Sumiyoshi Jinja Mae Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2024-07-21
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-09-30
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

  4. Hamilton Depression Rating Score (HDRS 17) of 19 or higher

  5. Montgomery Asberg Depression Rating Scale score of 20 or higher

  6. Any other patient deemed appropriate by the PI (subprincipal investigator)

• 4. With respect to taking antidepressants, any of the following

  5. not taking antidepressants

  6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Neurofeedback	-

Primary Outcome Measures

Name	Time	Method
HAMD21 change after intervention	4 weeks after the start of the intervention	HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline.

Secondary Outcome Measures

Name	Time	Method
HAMD21 after intervention	4 weeks after the start of the intervention	HAMD21(Hamilton Depression Rating Scale, 21-item version) score
MADRS after intervention	4 weeks after the start of the intervention	MADRS(Montgomery Åsberg Depression Rating Scale) score
HAMD21 remission rate	8 weeks after the start of the intervention	HAMD21(Hamilton Depression Rating Scale, 21-item version) remission rate (\<=7 points)
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	HAMD21(Hamilton Depression Rating Scale, 21-item version) score compared to baseline.
changes in brain activity	2 and 4 weeks after the start of the intervention	EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain
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	MADRS(Montgomery Åsberg Depression Rating Scale) score compared to baseline.
HAMD21 response rate	8 weeks after the start of the intervention	HAMD21(Hamilton Depression Rating Scale, 21-item version) response rate (\>=50% reduction)
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	PHQ-9(Patient Health Questionnaire-9) score
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	SDS(Self-rating Depression Scale) score compared to baseline.
duration of remission after the end of the intervention	up to 24 weeks 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)
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	Quality of life assessment (EQ-5D-3L(EuroQol 5 dimensions 3-level))

Trial Locations

Locations (1)

UNB Sumiyoshi Jinja Mae Clinic; 🇯🇵 Fukuoka, Japan