UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002541 |
|---|---|
| Receipt number | 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 23:31:09 |
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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
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
cheng-ta.li@nih.gov
Sponsor or person
Institute
National Science Council, Taiwan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003107
