NIPH Clinical Trials Search

Impact of Brain Functional Assessment on Treatment Outcomes in Major Depressive Disorder

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Major Depressive Disorder, MDD
Date of first enrollment	11/05/2026
Target sample size	360
Countries of recruitment
Study type	Interventional
Intervention(s)	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 feedback to both the subject and the attending physician. For the non-feedback group (control group), participants will undergo ERP assessments at the same time points as the feedback group, concurrent with treatment as usual. The results will be blinded to both the participants and the attending physicians, and routine clinical practice will proceed without reference to the ERP findings.

Outcome(s)

Primary Outcome

Remission rate (MADRS score of 10 or less) at Week 8 after the initial assessment

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Both
Include 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.
Exclude 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