Difficult-to-Treat Depression
Conditions
Interventions
Repetitive transcranial magnetic stimulation (rTMS) and individual cognitive behavioral therapy (CBT) will be administered. rTMS will be administered 4 to 5 times per week for a total of 30 sessions
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: 1. Diagnosis of Major Depressive Disorder according to DSM-IV 2. Total GRID-HAMD-17 score of 14 or higher 3. Insufficient improvement despite adequate treatment with at least one antidepressant, or difficulty in continuing antidepressant treatment due to adverse effects 4. Age between 18 and 70 years 5. Written informed consent voluntarily provided after adequate understanding of the purpose and procedures of the study
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1. Severe organic brain lesions (including moderate or greater intracranial lesions or neurodegenerative diseases) or cognitive impairment within the past year 2. History of seizure or epilepsy 3. Substance use disorder, including alcohol use disorder, within the past 12 months 4. Current or past hypomanic episode, manic episode, or psychotic disorder 5. Other Primary Axis I Disorders within the past 12 months 6. Clinically imminent suicidal ideation 7. Severe or unstable physical illness that may be life-threatening 8. ECT within the past 6 months 9. Previous treatment with rTMS 10. Previous individual CBT of 8 sessions or more 11. Planned structured psychotherapy other than supportive therapy during the intervention period 12. Pregnancy, breastfeeding, or planned pregnancy 13. Contraindications to rTMS or MRI, including metal implants, pacemaker, claustrophobia, or large tattoos in the head and neck region 14. Any other condition judged inappropriate by the principal investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are as follows. Symptom-related measures: GRID-HAMD-17 and MADRS, response rate (50 percent or greater improvement), remission rate (GRID-HAMD-17 score of 7 or less), and dropout rate. Satisfaction measure: CSQ-8J. Psychological-behavioral and neuroimaging measures: reaction time on the future thinking task (FT_RT), and changes in brain function and brain structure assessed by fMRI and structural MRI. Patient-reported outcomes: QIDS-J, SRS, SWLS, FS, RRS, EQ, and CBTSQ. Therapist-rated measure: CTRS-R. One recorded CBT session during the intervention period will be independently rated by an evaluator. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is change on the GRID-Hamilton Depression Rating Scale (GRID-HAMD-17). | — |
Countries
Japan
Contacts
Public ContactNariko Katayama
Keio University Health Center
Outcome results
None listed