UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016405 |
|---|---|
| Receipt number | R000019033 |
| Scientific Title | Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2019/08/08 17:13:14 |
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Basic information
Public title
Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Acronym
Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Scientific Title
Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Scientific Title:Acronym
Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Region
| Japan |
Condition
Condition
Major depressive disorder and bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the mechanism of recovery from depression following rTMS and the potential predictors of treatment response
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Near Infrared Spectroscopy (NIRS), MRI, and psychological tests
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Left dorsolateral prefrontal cortex high-frequency rTMS, or, right dorsolateral prefrontal cortex low-frequency rTMS
Interventions/Control_2
Patients without rTMS
Interventions/Control_3
Healthy volunteers without rTMS
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 who are diagnosed as major depressive disorder or bipolar disorder according to SCID, and healthy volunteers without psychiatric disorders
Key exclusion criteria
Subjects who are contraindicated for the use of MRI
Subjects do not have capability of informed consent
Subjects who are judged as unsuitable for participation in this study
Concerning the patients with rTMS, patients who are contraindicated for rTMS are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Yamashita |
Organization
Kyoto Prefectural Rakunan Hospital
Division name
Department of Psychiatry
Zip code
611-0011
Address
2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan
TEL
0774-32-5900
rakunanhp-shomu@pref.kyoto.lg.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Yamasaki |
Organization
Kyoto Prefectural Rakunan Hospital
Division name
Department of Psychiatry
Zip code
611-0011
Address
2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan
TEL
0774-32-5900
Homepage URL
rakunanhp-shomu@pref.kyoto.lg.jp
Sponsor or person
Institute
Kyoto Prefectural Rakunan Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rakunan Hospital Ethics Committee
Address
2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan
Tel
0774-32-5900
rakunanhp-shomu@pref.kyoto.lg.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
洛南病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 02 | 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
81
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
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was approved by the Ethics Committee at Kyoto Prefectural Rakunan Hospital under the title of "Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and neural responses following rTMS in major depression". The data partially overlap with the data in the study entitled "Neural responses following transcranial magnetic stimulation (rTMS) in major depression (UMIN000013493)"
Management information
Registered date
| 2015 | Year | 01 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019033
