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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002541
Receipt No. R000003107
Scientific Title Antidepressant mechanism of repetitive transcranial magnetic stimulation in treating medication-resistant depression
Date of disclosure of the study information 2009/09/24
Last modified on 2013/09/24

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Basic information
Public title Antidepressant mechanism of repetitive transcranial magnetic stimulation in treating medication-resistant depression
Acronym Antidepressant and antinociceptive mechanism of repetitive transcranial magnetic stimulation
Scientific Title Antidepressant mechanism of repetitive transcranial magnetic stimulation in treating medication-resistant depression
Scientific Title:Acronym Antidepressant and antinociceptive mechanism of repetitive transcranial magnetic stimulation
Region
Asia(except Japan)

Condition
Condition Major depression who were resistant to antidepressants
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate underlying mechanism of repetitive transcranial magnetic stimulation antidepressant efficacy using multiple neuroimaging modalities (MEG, MRI, 18F FDG-PET)
Basic objectives2 Others
Basic objectives -Others not for treatment efficacy but for investigating the metabolic differences between rTMS responders and non-responders
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes to see if neurobiological singals from multiple neuroimaging modalities could differentiate rTMS responders from non-responders
Key secondary outcomes to study neural correlates of rTMS antinociceptive effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 repetitive transcranial magnetic stimulation for medication-resistant depressives
Interventions/Control_2 no treatment in normal controls
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 Major depressive disorder and a history of medication resistance (> 2 kinds of antidepressants failures)
Key exclusion criteria Major systemic illness. Bipolar disorders. Cluster B personality. OCD and PTSD.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tung-Ping Tom Su
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry Department
Zip code
Address No.201, Sec.2, Shih-Pai Rd, Beitou District, Taipei, Taiwan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital,Taiwan
Division name Psychiatry Department
Zip code
Address
TEL
Homepage URL
Email cheng-ta.li@nih.gov

Sponsor
Institute National Science Council, Taiwan
Institute
Department

Funding Source
Organization National Science Council, Taiwan
Organization
Division
Category of Funding Organization
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
2009 Year 09 Month 24 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 24 Day
Last modified on
2013 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003107

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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