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New treatment option for Depression
Official title Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
ClinicalTrials.gov ID: NCT06557525
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 10\. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.