UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061196 |
|---|---|
| Receipt number | R000070005 |
| Scientific Title | rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/08 11:06:41 |
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Basic information
Public title
rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Randomized Controlled Trial
Acronym
T-COM Trial
Scientific Title
rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Randomized Controlled Trial
Scientific Title:Acronym
T-COM Trial
Region
| Japan |
Condition
Condition
Difficult-to-Treat Depression
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The primary outcome is change on the GRID-Hamilton Depression Rating Scale (GRID-HAMD-17).
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | 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 sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University School of Medicine
Division name
Health Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
narikoktym@keio.jp
Public contact
Name of contact person
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University
Division name
Health Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
narikoktym@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3971
narikoktym@keio.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070005
