Major depressive disorder Major depressive disorder
Conditions
Interventions
Repetitive transcranial magnetic stimulation
Sponsors
Sakuma Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The clinical trial will be described in detail to the individuals, and would be written informed consent will be obtained from all participants and their guardians 2. Individuals over 18 years old 3. Individuals will meet the DSM-5 criteria for major depressive disorder 4. Individuals who will be clinically stable by electroconvulsive therapy following treatment failure with antidepressant in the current episode (HAM-D17 total score of less than 8) DSM-5: Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition HAM-D17: 17-item Hamilton Rating Scale for Depression
Exclusion criteria
Exclusion criteria: 1. Individuals with metal implants or devices close to the stimulation site (e.g., cochlear implants, surgical clips with magnetic properties, or neurostimulators such as deep brain stimulation or vagus nerve stimulation), individuals with cardiac pacemaker 2. Individuals with metal implants or devices not close to the stimulation site (e.g., implanted medication pumps), titanium products in their heads, magnetic dentures/implants 3. Individuals with a history of seizures, a history of intracranial lesions at risk for seizures, individuals taking drugs that reduce seizure threshold (e.g.,methylphenidate or ketamine), individuals with alcohol/caffeine/stimulants abuse or withdrawal symptoms, pregnant individuals, individuals with severe physical disease 4. Individuals with a history of receiving repetitive transcranial magnetic stimulation in the current depressive episode 5. Individuals with dementia, organic or symptomatic mood disorder 6. Individuals with neurotic, stress-related and somatoform disorders including adjustment disorders, disorders of adult personality and behaviour, pervasive developmental disorders (autism spectrum disorder), or hyperkinetic disorders (attention-deficit/hyperactivity disorder) 7. Individuals with low adherence to antidepressants 8. Individuals with substance or medication-induced mood disorder 9. Individuals with bipolar disorder 10. First episode major depressive disorder 11. Individuals received electroconvulsive therapy during the current episode due to acute suicidal ideation, stupor, and psychotic symptoms 12. Individuals judged that researchers are inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate (relapse rate from baseline to week 26, relapse will be defined as the HAM-D17 total score of 8 or higher) HAM-D17: 17-item Hamilton Rating Scale for Depression | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relapse rate (relapse rate from baseline to week 2, 6, 10, 14, 18, 22, and 26) 2. Time to relapse 3. Improvement of depression symptoms (mean change from baseline to week 2, 6, 10, 14, 18, 22, and 26 in HAM-D17 total score, mean change from baseline to week 2, 6, 10, 14, 18, 22, and 26 in HAM-D21 total score) 4. Improvement of depression severity (mean change from baseline to week 2, 6, 10, 14, 18, 22, and 26 in CGI-S-BP depression score) 5. Improvement of mania severity (mean change from baseline to week 2, 6, 10, 14, 18, 22, and 26 in CGI-S-BP mania score) 6. All-cause discontinuation 7. Discontinuation due to adverse events 8. Incidence of total adverse events 9. Incidence of serious adverse events 10. Mortality rate 11. Incidences of individual adverse events CGI-S-BP: Clinical Global Impression-Severity Scale-Bipolar Version HAM-D (17, 21): (17-item, 21-item) Hamilton Rating Scale for Depression | — |
Contacts
Public ContactKenji Sakuma
Fujita Health University Hospital
Outcome results
None listed