Treatment-resistant depression(TRD)
Conditions
Interventions
Conventional sequential bilateral rTMS treatment
Novel sequential bilateral theta-burst stimulation rTMS treatment
Sponsors
Department of Neuropsychiatry, Keio University School of Medicine
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are attending the outpatient department or inpatient ward of the Department of Neuropsychiatry, Keio University Hospital (2) 18 years of age or older at the time of consent (3) Patients whose attending physician determines that written consent can be obtained. (4) Patients who meet the diagnostic criteria for depression according to the DSM-5 and the Mental Illness Inventory (MINI). (5) Meet score 3 or higher on the Antidepressant Treatment History Form (ATHF) for the current episode or have not responded to two different types of antidepressant treatment in the past. (6) Who demonstrate a severity of at least 18 points on the MADRS (7) Have a stable mental status to the extent that they are able to undergo prolonged testing.
Exclusion criteria
Exclusion criteria: (1) Persons with cerebral organic diseases (e.g., intracranial organic lesions of moderate severity or higher, neurodegenerative diseases, etc.) (2) History of convulsive seizures or epilepsy (3) Substance-related disorders in the past 6 months (4) Serious or unstable physical illness (5) Undergone rTMS treatment or ECT within the past 6 months (6) Any contraindication to TMS or MRI procedures such as metal implants, pacemakers, claustrophobia, etc. (7) Patients whose head, neck, or body size is not suitable for MRI scanner (8) Other cases that the principal investigator and subinvestigators deem inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All participants will received the following measures at time . Montgomery Asberg Depression Rating Scale (MADRS), 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J) Maintenance phase: Montgomery Asberg Depression Rating Scale (MADRS), 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J) | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute phase: 17-Item Hamilton Rating Scale for Depression (HRSD-17), Brief Symptom Inventory-anxiety subscale (BSI-anxiety), Beck Suicide Scale for Suicide Ideation (BSS), Pittsburgh Sleep Quality Index (PSQI) Montreal Cognitive Assessment (MoCA), California Verbal Learning Test Second Edition (CVLT-II), Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Letter Number Sequencing Test (LNST), Stroop Neuropsychological Screening Test (SNST), Trail Making Test (TMT), The Executive Interview (EXIT25) Resting-state EEG (rs-EEG), MRI (T1, resting-state fMRI (rs-fMRI), DTI, MRS), Polysomnography (PSG), Holter ECG, Capillary Electrophoresis Mass Spectrometry (CE-MS), Liquid Chromatography Mass Spectrometry (LC-MS) Maintenance phase: 17-Item Hamilton Rating Scale for Depression (HRSD-17), Brief Symptom Inventory-anxiety subscale (BSI-anxiety) Resting-state EEG (rs-EEG), Auditory Steady State Response (ASSR), Capillary Electrophoresis Mass Spectrometry (CE-MS), Liquid Chromatography Mass Spectrometry (LC-MS) | — |
Countries
Japan,North America
Contacts
Public ContactYoshihiro Noda
Keio University School of Medicine Neuropsychiatry
Outcome results
None listed