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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038578
Receipt No. 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

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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
Email 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
Email kodaka@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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