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NCT Number: NCT06557525

Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UNB Sumiyoshi Jinja Mae Clinic

Fukuoka, 812-0018, Japan

Location status: Recruiting

Location contact

Hiroaki Harashima

CONTACT

[email protected]

092-477-1101

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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)
  • 4. 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.
  • 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.

Treatment and study plan

Neurofeedback

Behavioral

Subjects will receive neurofeedback training by visual stimulation using a software program on a PC or tablet (monitor) with reference to EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain. The DLPFC status of the subject's brain is then fed back to the subject to continue stimulating the subject's reward system. Before and after these neurofeedback training sessions, fMRI imaging will be performed to confirm changes in brain activity.

Primary outcomes

  1. 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

  1. HAMD21 compared to baseline

    Time frame: 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.

  2. MADRS compared to baseline

    Time frame: 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.

  3. SDS compared to baseline

    Time frame: 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.

  4. HAMD21 after intervention

    Time frame: 4 weeks after the start of the intervention

    HAMD21(Hamilton Depression Rating Scale, 21-item version) score

  5. MADRS after intervention

    Time frame: 4 weeks after the start of the intervention

    MADRS(Montgomery Åsberg Depression Rating Scale) score

  6. HAMD21 response rate

    Time frame: 8 weeks after the start of the intervention

    HAMD21(Hamilton Depression Rating Scale, 21-item version) response rate (>=50% reduction)

  7. HAMD21 remission rate

    Time frame: 8 weeks after the start of the intervention

    HAMD21(Hamilton Depression Rating Scale, 21-item version) remission rate (<=7 points)

  8. duration of remission after the end of the intervention

    Time frame: 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)

  9. Quality of life assessment (EQ-5D-3L)

    Time frame: 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))

  10. PHQ-9 score

    Time frame: 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

  11. changes in brain activity

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hiroaki Harashima

CONTACT

[email protected]

092-477-1101

Sponsors and collaborators

Lead sponsor

UNB Sumiyoshi Jinja Mae Clinic

Other

Collaborators

  • Universal Brain, LLC

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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