UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038578 |
|---|---|
| Receipt number | R000043963 |
| Scientific Title | Treatment mechanism of anhedonia by repetitive Transcranial Magnetic Stimulation in major depressive disorder: analysis using rs-fMRI |
| Date of disclosure of the study information | 2019/11/14 |
| Last modified on | 2019/11/14 11:24:59 |
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Basic information
Public title
Treatment mechanism of anhedonia by repetitive Transcranial Magnetic Stimulation in major depressive disorder: analysis using rs-fMRI
Acronym
Treatment mechanism of anhedonia by repetitive Transcranial Magnetic Stimulation in major depressive disorder
Scientific Title
Treatment mechanism of anhedonia by repetitive Transcranial Magnetic Stimulation in major depressive disorder: analysis using rs-fMRI
Scientific Title:Acronym
Treatment mechanism of anhedonia by repetitive Transcranial Magnetic Stimulation in major depressive disorder
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate treatment mechanism of anhedonia by repetitive Transcranial Magnetic Stimulation using rs-fMRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in inter-regional functional connectivity of salience network by rTMS
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) participation in a research "effect of rTMS on cognitive function in depressive episode" which is main protocol of this study.
2) those who can read and understand infromed consent form of this study.
3) major depressive disroder according to Diagnostic and Statistical Manual of Mental
Disorders.
4) those who are 20-75 years old
Key exclusion criteria
1) those who have a history of psychotic episode, obsessive compulsive disorder, post traumatic stress disorder and/or eating disorder.
2) those who have a history of electro-convulsive therapy, rTMS, vagus nerve stimulation, deep brain stimulation and/or transcranial direct current stimulation.
3) those who are pregnant.
4) those who have a history of a episode of convulsion by epilepsy and have relatives with epilepsy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8471
Address
3-18-13 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
TEL
+81-3-3433-1111
kodaka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8471
Address
3-18-13 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
TEL
+81-3-3433-1111
Homepage URL
kodaka@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-18-13 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
Tel
+81-3-3433-1111
kodaka@jikei.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
| 2019 | Year | 11 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observe the treatment efficacy by rs-fMRI
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043963
