None listed
Conditions
Interventions
Medical Device : The intervention in this study is a non-invasive brain stimulation treatment — connectivity-evidence-based standardized coordinate neuronavigation accelerated intermittent theta burst
Blumberger et al., 2018
2022). Specifically, the standard coordinate is reverse co-registered to each participants T1 structural MRI image acquired at screening to determine an individually tailored left DLPFC target, which
in cases of missed sessions, make-up sessions are permitted for up to a maximum of 3 weeks, provided that the total number of treatment days — including both scheduled a
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to 65 years, inclusive, of either sex. 2) Diagnosis of major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, as assessed using the Mini-International Neuropsychiatric Interview (MINI). 3) Moderate to severe depressive symptoms, defined as a score of 18 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17). 4) A score of = 2 on the Massachusetts General Hospitals Staging Method to classify treatment resistant depression (MGH-TRD) staging system for the current major depressive episode. 5) Patients who have been receiving the same antidepressant medication for at least 4 weeks prior to baseline (Week 0) and are able to maintain the same antidepressant regimen throughout the study period (6 weeks). Initiation or dose adjustment of benzodiazepines for sleep regulation purposes is permitted. 6) Ability and willingness to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: - Psychiatric Criteria 1) A current or past diagnosis of schizophrenia spectrum disorders, bipolar disorder, substance use disorders (excluding nicotine use disorder), neurocognitive disorders, organic mental disorders, or neurodevelopmental disorders, or the presence of any other comorbid psychiatric disorder that constitutes the primary diagnosis rather than major depressive disorder. 2) A current or past major depressive episode with psychotic features. 3) A current or past major depressive episode with mixed features. 4) A current or past history of hypomanic symptoms or mood switching induced by pharmacological treatment or neuromodulation therapies. 5) Presence of active suicidal ideation, or suicidal intent or plan, defined as endorsement of items 3, 4, or 5 on the suicidal ideation section (past 1 month) of the Korean version of the Columbia–Suicide Severity Rating Scale (C-SSRS). 6) Patients who pose an imminent risk of harm to others requiring immediate clinical intervention. 7) Presence of a clinically significant personality disorder. 8) A Full-Scale Intelligence Quotient (IQ) of 70 or below. - Medical Criteria 1) Presence of neurological abnormalities or medical conditions that may affect brain function, including but not limited to history of traumatic brain injury, epilepsy, multiple sclerosis, brain tumors, or cerebrovascular disease. 2) Any contraindication to magnetic resonance imaging (MRI), such as the presence of metallic implants or foreign bodies. 3) Claustrophobia. 4) Pregnant or breastfeeding women, or individuals who are planning pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score of the 17-item Hamilton Depression Rating Scale (HDRS-17) | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery–Åsberg Depression Rating Scale (MADRS) total score;Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR) total score;Beck’s Scale for Suicidal Ideation (K-SSI) total score;Hamilton Anxiety Rating Scale (HARS) total score;Beck Anxiety Inventory (BAI) total score;Clinical Global Impression–Severity (CGI-S) and Clinical Global Impression–Improvement (CGI-I);Korean version of the Rumination Response Scale (K-RRS) total score;Snaith–Hamilton Pleasure Scale (SHAPS) total score;Korean version of the Difficulties in Emotion Regulation Scale (K-DERS) total score;17-item Hamilton Depression Rating Scale (HDRS-17) total score | — |
Countries
Korea, Republic of
Contacts
Public ContactMinjee Jung
Korea University
Outcome results
None listed