Major Depressive Disorder, MDD Major Depressive Disorder, MDD
Conditions
Interventions
In the ERP monitoring group (Intervention group), reports of ERP measurements performed at each designated assessment timepoint (Baseline, Week 2, Week 4, Week 8, and Week 24) will be provided as feed
ERP. Event-Related Potential, Feedback, Brain Function Monitoring
Sponsors
Okuda Kazutaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 to 65 years at the time of consent. 2.Diagnosed with Major Depressive Disorder (MDD) or exhibiting equivalent depressive symptoms. 3.PHQ-9 score of 6 or higher. 4.Currently receiving treatment from a psychiatrist. 5.Capable of providing voluntary written informed consent and has signed the study consent form. 6.Competent to consent to participate in the study and capable of performing tasks on a PC.
Exclusion criteria
Exclusion criteria: 1. History of bipolar disorder, psychotic disorder, or dementia 2. Current medical condition that, in the opinion of the study physician, significantly contributes to mood disorder symptoms 3. Cognitive impairment, memory loss, dementia, delirium, or other cognitive dysfunction that, in the judgment of the study physician, may interfere with the participant's ability to comply with study requirements or confound the assessment of MDD (Major Depressive Disorder) symptoms 4. Currently pregnant or planning to become pregnant during study participation 5. Current or past history of substance dependence (drugs or alcohol) 6. Currently participating in another clinical trial or clinical study (observational studies are excluded) 7. Any condition that, in the judgment of the study physician, would interfere with the appropriate evaluation of the safety and performance of the device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate (MADRS score of 10 or less) at Week 8 after the initial assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate (defined as a reduction in MADRS score of 50% or greater) at Week 8 post-baseline. 2. Time to remission (defined as a MADRS score of 10 or less) from the initial assessment. 3. Change from baseline at Weeks 2, 4, 8, and 24 after the start of intervention in: a. HAMD (Hamilton Rating Scale for Depression) total score b. MADRS (Montgomery-Asberg Depression Rating Scale) total score 4. WAI (working alliance inventory) score at Weeks 2,8 | — |
Contacts
Public ContactYoshiki Akizuki
Office of the President
Outcome results
None listed