Tokyo, April 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061196) titled 'rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Randomized Controlled Trial' on April 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Difficult-to-Treat Depression
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to evaluate the efficacy of combined repetitive transcranial magnetic stimulation (rTMS) plus cognitive behavioral therapy (CBT) for difficult-to-treat depression (DTD).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 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 over up to 8 weeks. CBT will be provided once weekly for 50 minutes per session, for a total of 12 sessions over 12 weeks.
Interventions/Control_2 - Repetitive transcranial magnetic stimulation (rTMS) will be administered.
rTMS will be administered 4 to 5 times per week for a total of 30 sessions over up to 8 weeks. Cognitive behavioral therapy (CBT) will not be provided.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key 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
Key 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
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 19 Day
Anticipated trial start date - 2026 Year 04 Month 22 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070005
Disclaimer: Curated by HT Syndication.
