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Recruiting Phase 1, Phase 2 NCT06557525

NCT06557525 Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

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Clinical Trial Summary
NCT ID NCT06557525
Status Recruiting
Phase Phase 1, Phase 2
Sponsor UNB Sumiyoshi Jinja Mae Clinic
Condition Depression
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2023-11-20
Primary Completion 2024-09-30

Trial Parameters

Condition Depression
Sponsor UNB Sumiyoshi Jinja Mae Clinic
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-20
Completion 2024-09-30
Interventions
Neurofeedback

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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).

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 b

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