Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

Last updated: August 13, 2024
Sponsor: UNB Sumiyoshi Jinja Mae Clinic
Overall Status: Active - Recruiting

Phase

1/2

Condition

Depression

Treatment

Neurofeedback

Clinical Study ID

NCT06557525
frontier
  • Ages > 18
  • All Genders

Study 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

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 theprogram.

  1. If receiving psychotherapy, agree to continue the same psychotherapy for theduration 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

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 orneurodegenerative 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 participatedin a clinical trial within the past 90 days, or are scheduled to participate inanother clinical trial during the study period, and the principal (sub)investigator determines that participation in another clinical trial mayinterfere with the results of this study
  1. Other cases in which the principal investigator (or subinvestigator) determinesthat it is difficult to conduct this study safely.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Neurofeedback
Phase: 1/2
Study Start date:
November 20, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • UNB Sumiyoshi Jinja Mae Clinic

    Fukuoka, 812-0018
    Japan

    Active - Recruiting

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