UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019795 |
|---|---|
| Receipt number | 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 19:41:16 |
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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
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
inishimu@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022861
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
