A treatment option for Medication-resistant depression
Conditions
Interventions
Inhibitory OFC group (2 sessions/day, 50 mins inter-session, 5 days/week, total 2 weeks and 20 sessions) by 90BFVT-LQC coil
Excitatory OFC group (2 sessions/day, 50 mins inter-session, 5 days/week, to
Sponsors
Taipei Veterans General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be able to read, understand, and sign the informed consent form before assessment, and must be able to comply with the study procedures. 2. Participants must meet the DSM-5 criteria for major depressive disorder, recurrent episode, and the current major depressive episode must have lasted for more than 2 weeks. 3. Participants must have at least a moderate level of depressive symptom severity, defined as a 17-item Hamilton Depression Rating Scale (HDRS-17) score of >=18 and a Clinical Global Impression-Severity (CGI-S) score of >=4. 4. Participants must have no major medical or surgical illnesses. 5. History of antidepressant treatment response: Participants must have a history of inadequate response to at least one antidepressant treatment of adequate dose and duration, defined as less than 50% improvement after treatment with an adequate antidepressant regimen, such as escitalopram 10-20 mg/day or an equivalent antidepressant dose, for at least 8 weeks. 6. If participants are receiving concomitant antidepressant medication at study entry, the dosage must have remained stable for at least 4 weeks prior to enrollment and should remain unchanged during the brain stimulation treatment period. If participants are receiving concomitant psychotherapy, the psychotherapy must have been stable for at least 3 months before trial entry, with no anticipated change in treatment frequency.
Exclusion criteria
Exclusion criteria: 1. Participants with a diagnosis of bipolar I or II disorder, schizophrenia, organic brain syndrome, obsessive-compulsive disorder, or major neurocognitive disorder. 2. Participants with a history of substance use disorder within the past 6 months, or those with alcohol or benzodiazepine withdrawal symptoms. 3. Participants who have previously undergone or are scheduled to undergo brain surgery, or who have metallic implants in the brain, such as neurostimulators, or major intracranial abnormalities that may affect safety or confound interpretation of study results, such as brain tumors or arteriovenous malformations. Participants with a family history of epilepsy will also be excluded. 4. Participants with metallic implants or cardiac pacemakers in the body. 5. Participants with severe suicidal ideation within the past week, defined as a score of 4 on item 3, suicidality, of the Hamilton Depression Rating Scale. 6. Women who are pregnant or may be pregnant. 7. Participants who have previously received electroconvulsive therapy but showed less than 50% improvement in depressive symptoms. 8. Participants who have previously received prefrontal repetitive transcranial magnetic stimulation. 9. Participants with anxiety in confined spaces or claustrophobia who are unable to undergo magnetic resonance imaging (MRI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the 17-item Hamilton Depression Rating Scale score from baseline to Week 2 after OFC brain stimulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include changes from baseline to post-treatment and follow-up assessments in resting-state functional connectivity, structural MRI connectivity, EEG, paired-pulse TMS-EEG indices,fNIRS, cognitive function, and clinical symptom measures. Cognitive function will be assessed using the Go/No-Go task, Trail Making Test Part A and Part B, word list recall, and Wisconsin Card Sorting Test. Clinical outcomes include response and remission rates based on HDRS-17 and MADRS, as well as changes in MADRS, HAM-A, DSSS depression and somatic subscales, CGI, YMRS, RRS, SHAPS, UCLA Loneliness Scale, DERS, TCQ, AES, HAQ, PHQ-15, and BDI-II. Exploratory analyses will evaluate whether baseline clinical characteristics, Maudsley Staging Method, TRDSS, and multimodal biomarkers predict treatment response, and whether changes in depressive symptoms are associated with changes in neuroimaging, EEG, and TMS-EEG biomarkers. | — |
Countries
Asia(except Japan)
Contacts
Public ContactChih-Ming Cheng
Taipei Veterans General Hospital Department of Psychiatry
Outcome results
None listed