DepressionPhase 1/2NCT06557525
Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
A Phase 1/2 study testing Neurofeedback in people with Depression, run by UNB Sumiyoshi Jinja Mae Clinic at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Neurofeedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 20 Nov 2023to 31 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
UNB Sumiyoshi Jinja Mae Clinic
Fukuoka, 812-0018
Hiroaki Harashima, 092-477-1101, study@unbclinic.com
About this study
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
- Depression
- Being tested
- Neurofeedback
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
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 activity.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Not described Receives: Behavioral: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD21 change after intervention
HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline.
Measured: 4 weeks after the start of the intervention
Secondary outcomes (11)
HAMD21 compared to baseline
HAMD21(Hamilton Depression Rating Scale, 21-item version) score compared to baseline.
Measured: 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
MADRS(Montgomery Åsberg Depression Rating Scale) score compared to baseline.
Measured: 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
SDS(Self-rating Depression Scale) score compared to baseline.
Measured: 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
HAMD21(Hamilton Depression Rating Scale, 21-item version) score
Measured: 4 weeks after the start of the intervention
MADRS after intervention
MADRS(Montgomery Åsberg Depression Rating Scale) score
Measured: 4 weeks after the start of the intervention
HAMD21 response rate
HAMD21(Hamilton Depression Rating Scale, 21-item version) response rate (>=50% reduction)
Measured: 8 weeks after the start of the intervention
HAMD21 remission rate
HAMD21(Hamilton Depression Rating Scale, 21-item version) remission rate (<=7 points)
Measured: 8 weeks after the start of the intervention
duration of remission after the end of the intervention
duration of remission if remission occurred after the end of the intervention in HAMD21(Hamilton Depression Rating Scale, 21-item version)
Measured: up to 24 weeks after the end of the intervention
Quality of life assessment (EQ-5D-3L)
Quality of life assessment (EQ-5D-3L(EuroQol 5 dimensions 3-level))
Measured: 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
PHQ-9(Patient Health Questionnaire-9) score
Measured: 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
EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain
Measured: 2 and 4 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start20 Nov 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNB Sumiyoshi Jinja Mae Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Universal Brain, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557525
- Sponsor's protocol ID
- frontier
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
- ClinicalTrials.gov ID
- NCT06557525
- Acronym / sponsor ID
- frontier
- Conditions
- Depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UNB Sumiyoshi Jinja Mae ClinicUniversity, hospital or other
- Collaborators
- Universal Brain, LLC
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Behavioral: Neurofeedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 4. With respect to taking antidepressants, any of the following
- 5. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackSubjects 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 activity. | Behavioural | Neurofeedback |
Primary outcome
HAMD21 change after intervention
Time frame: 4 weeks after the start of the intervention
HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline.
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neurofeedback in people with Depression, run by UNB Sumiyoshi Jinja Mae Clinic at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroaki Harashima (092-477-1101, study@unbclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD21 change after intervention (time frame: 4 weeks after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.