UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026122 |
|---|---|
| Receipt number | R000029909 |
| Scientific Title | A preliminary study of a predictor of treatment response to transcranial magnetic stiumulation in treatment-resistant depression |
| Date of disclosure of the study information | 2017/02/14 |
| Last modified on | 2019/03/20 13:40:24 |
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Basic information
Public title
A preliminary study of a predictor of treatment response to transcranial magnetic stiumulation in treatment-resistant depression
Acronym
Transcranial magnetic stiumulation in treatment-resistant depression
Scientific Title
A preliminary study of a predictor of treatment response to transcranial magnetic stiumulation in treatment-resistant depression
Scientific Title:Acronym
Transcranial magnetic stiumulation in treatment-resistant depression
Region
| Japan |
Condition
Condition
Treatment-resistant depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy of and exploration and identification of a predictor of treatment response to transcranial magnetic stimulation in treatment-resistant depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of depressive symptoms from the start point to eight weeks later
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcranial magnetic stimulation, dorsolateral prefrontal cortex, 4 weeks, 10 Hz, 100-120% MT (motor threshold), 4 sec, 3000 pulsed/day, 5 days/week
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed as major depression by DSM-5
Larger than 14 in the score of HAMD 17
Less than three years in the period of the most recent depressive episode
Treatment-resistant in the present depressive episode
Key exclusion criteria
History of psychotic episode, bipolar disorder, obsessive-compulsive disorder, PTSD, or eating disorder
History of treatment of ECT, TMS, VNS, DBS, or tDCS
Pregnancy
History of convulsive disorder including epilepsy
History of neurological or organic brain disease
Diagnosed as drug or alcohol dependence
Magnetic substance in a body including pace-maker, cochlear implant, or intracranial clip
Having severe state of diseases of endocrine or metabolic system
Having severe level of suicide idea
Treated with the medicines which taper the convulsion thresholds
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Tochigi |
Organization
Teikyo University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi
TEL
03-3964-1211
mtoc-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Tochigi |
Organization
Teikyo University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi
TEL
03-3964-1211
Homepage URL
mtoc-tky@umin.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethics Committee
Address
2-11-1, Kaga, Itabashi
Tel
03-3964-7256
turb-office@teikyo-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 14 | 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
15
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
| 2017 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029909
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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