Actively Recruiting
Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
Led by UNB Sumiyoshi Jinja Mae Clinic · Updated on 2024-08-16
30
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
Sponsors
U
UNB Sumiyoshi Jinja Mae Clinic
Lead Sponsor
U
Universal Brain, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults at least 18 years old at the time of consent
- Diagnosis of major depressive episode as defined by DSM 5 criteria
- Hamilton Depression Rating Score (HDRS 17) of 19 or higher, or Montgomery Asberg Depression Rating Scale score of 20 or higher, or deemed appropriate by the principal investigator
- Either not taking antidepressants or willing to continue current antidepressants during the study
- If receiving psychotherapy, agree to continue the same psychotherapy during study participation
- Have been treated by a psychiatrist
- Provide written informed consent
- No planned change in employment status after the study begins
You will not qualify if you...
- High risk of suicide, including suicidal thoughts or attempts
- History of hospitalization for depression or suicidal behavior
- Current or past addictions to drugs or alcohol
- Organic brain disease such as moderate or severe brain lesions or neurodegenerative disease
- History of seizures or epilepsy
- Serious or unstable physical illness
- Unable or unsuitable for MRI imaging
- Pregnant or unwilling to use contraception during the study
- Participation in another clinical trial currently, within the past 90 days, or planned during this study if it may interfere
- Any other condition making safe study participation difficult as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UNB Sumiyoshi Jinja Mae Clinic
Fukuoka, Japan, 812-0018
Actively Recruiting
Research Team
H
Hiroaki Harashima
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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