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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019795
Receipt No. R000022861
Scientific Title Study on predictive factors for therapeutic effect of rTMS on major depressive disorder
Date of disclosure of the study information 2015/12/01
Last modified on 2018/07/24

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Basic information
Public title Study on predictive factors for therapeutic effect of rTMS on major depressive disorder
Acronym Predictive factors for therapeutic effect of rTMS on major depression
Scientific Title Study on predictive factors for therapeutic effect of rTMS on major depressive disorder
Scientific Title:Acronym Predictive factors for therapeutic effect of rTMS on major depression
Region
Japan

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

Objectives
Narrative objectives1 To study predictive factors for therapeutic effect of rTMS (repetitive Transcranial Magnetic Stimulation) on major depressive disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hamilton Depression Rating Scale (HAM-D)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 rTMS on the dorsolateral prefrontal cortex for 4 weeks
Interventions/Control_2 patients without 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with a DSM-5 diagnosis of major depressive disorder. The current depressive episode has a total score of at least 16 on the 17-item Hamilton Depression Rating Scale (HAM-D).
Key exclusion criteria A history of other mental disorders; patients with a intracranial space-occupying lesion; patients with a history of head injury; patients with comorbid neurological disease; a personal or close family history of a seizure disorder; patients who develop epileptiform discharge on EEG; pregnancy; presence of physical disease or medication therapy known to alter seizure threshold presence of ferromagnetic material in or in close proximity to the head; presence of ferromagnetic material in the body; patients with emergent suicidal ideation; patients with stupor; patients who received electroconvulsive therapy in the past month; patients with substance/medication-induced depressive disorder; patients with depressive disorder due to another medical conditions.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nishimura, Isao
Organization Kyoto Prefectural University of Medicine
Division name Department of Psychiatry
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5033
Email inishimu@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nishimura, Isao
Organization Kyoto Prefectural University of Medicine
Division name Department of Psychiatry
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5033
Homepage URL
Email inishimu@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University 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
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 京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 01 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 Terminated
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 16 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022861

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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