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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001157
Receipt No. R000001406
Scientific Title The therapeutic efficacy of transcranial magnetic stimulation for major depressive disorder; A brain functional imaging study
Date of disclosure of the study information 2008/05/15
Last modified on 2009/05/29

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Basic information
Public title The therapeutic efficacy of transcranial magnetic stimulation for major depressive disorder; A brain functional imaging study
Acronym The therapeutic efficacy of transcranial magnetic stimulation for major depression
Scientific Title The therapeutic efficacy of transcranial magnetic stimulation for major depressive disorder; A brain functional imaging study
Scientific Title:Acronym The therapeutic efficacy of transcranial magnetic stimulation for major depression
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate the relationship between the therapeutic efficacy of transcranial magnetic stimulation and regional cerebral blood flow.
Basic objectives2 Others
Basic objectives -Others We aim to investigate the therapeutic efficacy associated with regional cerebral blood flow.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes We will evaluate regional cerebral blood flow associated with the therapeutic efficacy of transcranial magnetic stimulation.
Key secondary outcomes

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
Interventions/Control_1 We will stimulate left dorsolateral prefrontal cortex with high-frequency over 3 weeks.
Interventions/Control_2 We will stimulate right dorsolateral prefrontal cortex with low-frequency over 3 weeks.
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
25 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who meet with DSM-IV-TR criteria for major depressive disorder
Key exclusion criteria Exculsion criteria includes severe medical illness, a history of convulsive disorder, and severe suicide idea.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Kito
Organization Kyorin University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Kito
Organization Kyorin University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL 0422-47-5511
Homepage URL
Email psychiat@kyorin-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2008 Year 05 Month 15 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 Completed
Date of protocol fixation
2008 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 05 Month 15 Day
Last modified on
2009 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001406

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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