Exploring Neurofeedback Therapy for Depression

Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

This study is testing a new brain training method called neurofeedback to see if it can help people with depression feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UNB Sumiyoshi Jinja Mae Clinic (Academic / other)
• Locations: 1 site (Fukuoka)
• Trial ID: NCT06557525 on ClinicalTrials.gov

What this trial studies

This exploratory study aims to evaluate the effectiveness of a novel EEG neurofeedback method in treating patients with depression. Participants will undergo neurofeedback interventions, and their depressive symptoms will be assessed using the Depression Rating Scale before and after the treatment. Additionally, brain activity changes will be monitored through fMRI to understand the neurological impact of the therapy. The study will compare symptom changes over the treatment period to determine the efficacy of this approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are experiencing a major depressive episode and meet specific severity criteria.

Not a fit: Patients with a high risk of suicide or a history of hospitalization for depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new, non-invasive treatment option for individuals suffering from depression.

How similar studies have performed: While neurofeedback therapy is a growing field, the specific approach being tested in this study is novel and has not been extensively validated in previous studies.

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.

Where this trial is running

Fukuoka

• UNB Sumiyoshi Jinja Mae Clinic — Fukuoka, Japan (Recruiting)

Study contacts

• Study coordinator: Hiroaki Harashima

Conditions Depression