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Recruiting NCT06557525

Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

Phase I / Phase II Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurofeedback.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral Neurofeedback
    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

Primary outcome measures

  • HAMD21 change after intervention [Time frame: 4 weeks after the start of the intervention]
Secondary outcome measures (11)
  • 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]
  • 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]
  • 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]
  • HAMD21 after intervention [Time frame: 4 weeks after the start of the intervention]
  • MADRS after intervention [Time frame: 4 weeks after the start of the intervention]
  • HAMD21 response rate [Time frame: 8 weeks after the start of the intervention]
  • HAMD21 remission rate [Time frame: 8 weeks after the start of the intervention]
  • duration of remission after the end of the intervention [Time frame: up to 24 weeks after the end of the intervention]
  • 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]
  • 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]
  • changes in brain activity [Time frame: 2 and 4 weeks after the start of the intervention]

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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 1 center
  • UNB Sumiyoshi Jinja Mae Clinic — Fukuoka

Identifiers

NCT: NCT06557525 · frontier

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗