UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057631 |
|---|---|
| Receipt number | R000065844 |
| Scientific Title | Intervention study of D-MCT and rTMS in combination with rTMS for metacognition in depressed patients |
| Date of disclosure of the study information | 2025/04/16 |
| Last modified on | 2025/04/16 17:23:45 |
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Basic information
Public title
Study on the combination of D-MCT and rTMS
Acronym
MAGNET MCT And Guided Neurostimulation for Effective Treatment
Scientific Title
Intervention study of D-MCT and rTMS in combination with rTMS for metacognition in depressed patients
Scientific Title:Acronym
MAGNET MCT And Guided Neurostimulation for Effective Treatment
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will determine the combined effects of rTMS and D-MCT on metacognition in depressed patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MetaCognitions Questionnaire 30
Key secondary outcomes
Tri-Axial Coping Scale
Hamilton Depression Scale
Beck's Depression Inventory
Discontinuation rates for rTMS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
In parallel with rTMS treatment, D-MCT will be conducted once a week for a total of 8 sessions.
Interventions/Control_2
rTMS
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Person with major depressive disorder admitted to our hospital for rTMS
2 Person aged between 18 and 65 years
3 Person understand the content of the study and can give their consent to participate in the study by signing a consent form.
Key exclusion criteria
1 Person with psychotic symptomatic episodes, apparent dementia or organic or symptomatic mood disorders, adult personality and behavioural disorders, pervasive developmental disorders, hyperactivity disorder
2 Person have not improved with rTMS treatment in the past
3 Person with a history of epileptic seizures in themselves or in close relatives
4 Person have a metal or pacemaker in the body or near the head
5 Pregnant women
6 Person is taking drugs that lower the seizure threshold
7 Cases with markedly reduced adherence to antidepressants
8 Cases with residual emotional disturbance due to psychoactive substance or drug use
9 Person with intellectual disability
10 Person is deemed unsuitable by the person in charge of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Mouri |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Rehabilitation Science
Zip code
654-0142
Address
Tomogaoka 7-10-2, Suma-ku, Kobe, Hyogo 654-0142, Japan
TEL
078-382-6065
kmoris@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kurihara |
Organization
Kobe University Hospital
Division name
Rehabiritation
Zip code
650-0017
Address
Kusunokucho 7-5-1, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6065
Homepage URL
otkyuki@kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kobe University Hospital
Address
Kusunokucho 7-5-2, Chuo-ku, Kobe, Hyogo 650-0017, Japan
Tel
0783825400
kainyu@med.kobe-u.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
| 2025 | Year | 04 | Month | 16 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 08 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065844
