UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054747 |
|---|---|
| Receipt number | R000062564 |
| Scientific Title | A multisite observational study on the effectiveness of repetitive transcranial magnetic stimulation therapy for patients with treatment-resistant depression under health insurance coverage in Japan |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/04/03 11:48:44 |
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Basic information
Public title
A multisite observational study on the effectiveness of repetitive transcranial magnetic stimulation therapy for patients with treatment-resistant depression under health insurance coverage in Japan
Acronym
Observational study of repetitive transcranial magnetic stimulation therapy for patients with depression in Japan
Scientific Title
A multisite observational study on the effectiveness of repetitive transcranial magnetic stimulation therapy for patients with treatment-resistant depression under health insurance coverage in Japan
Scientific Title:Acronym
Multisite real-world rTMS study for TRD in Japan
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effectiveness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HAMD-17 score from baseline to endpoint
Key secondary outcomes
Change in MADRS score from baseline to endpoint
Change in PHQ-9 score from baseline to endpoint
Response rate and remission rate at 3 and 6 weeks
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients diagnosed with major depressive disorder according to DSM-5 criteria by a psychiatrist
Patients with moderate to severe depressive symptoms who have not responded to adequate doses and duration of antidepressant therapy during the current episode
Key exclusion criteria
Patients with psychotic features, bipolar disorder, mild depressive episodes, persistent depression
Patients with active suicidal ideation
Patients with ferromagnetic implants in the upper body (cardiac pacemakers, cochlear implants, ferromagnetic intracranial aneurysm clips, and deep brain stimulation)
Patients who have received rTMS therapy in the current episode
Patients with residual affective disorders due to psychoactive substance use and polypharmacy
Patients with a diagnosis of dementia, organic or symptomatic psychiatric disorder.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Noda |
Organization
International University of Health and Welfare
Division name
Department of Psychiatry
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo
TEL
03-3451-8121
yoshi-tms@keio.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsuda |
Organization
Fujita Health University
Division name
Department of Development and Education of Clinical Research
Zip code
470-1192
Address
1-98, Dengaku-kubo, Kutsukake-cho, Toyoake City, Aichi
TEL
0562-93-2000
Homepage URL
myuki@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Medical Research Ethics Committee
Address
1-98, Dengaku-kubo, Kutsukake-cho, Toyoake City, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.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
| 2024 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.psychres.2024.116263
Number of participants that the trial has enrolled
497
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will use data collected from the study "TMS Database Registry Consortium Research in Japan (TReC-J)" to retrospectively collect and analyze clinical data on rTMS therapy conducted under insurance coverage at 21 facilities in Japan from June 5, 2019, to December 31, 2023.
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062564
