UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004457 |
|---|---|
| Receipt number | R000003767 |
| Scientific Title | Transcranial Magnetic Stimulation in the treatment of major depression in cancer |
| Date of disclosure of the study information | 2010/10/27 |
| Last modified on | 2011/04/18 17:52:07 |
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Basic information
Public title
Transcranial Magnetic Stimulation in the treatment of major depression in cancer
Acronym
Transcranial Magnetic Stimulation in the treatment of major depression in cancer
Scientific Title
Transcranial Magnetic Stimulation in the treatment of major depression in cancer
Scientific Title:Acronym
Transcranial Magnetic Stimulation in the treatment of major depression in cancer
Region
| Japan |
Condition
Condition
Major depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the efficacy of transcranial magnetic stimulation (TMS) for depression in cancer patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HAM-D
Key secondary outcomes
MADRS,VAS,CGI
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
TMS are performed with a frequency of 10Hz, trains of 6s, inter-train-intervals of 60s, 15 trains per session, 2 sessions per day on 10 working days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients:
1)are now under treatment in National Cancer Center Hospital East
2)are at least 20 years old and over
3)have a moderate or severe major and minor depressive episode meeting DSM-4 criteria
4)are not able to take antidepressants
Key exclusion criteria
Patients:
1)who is not able to understand this study because of dementia, delirium, or other cognitive disorder
2)have brain metastasis
3)have neurological illness (e.g. epilepsy, meningitis)
4)had a history of convulsions
5)have a risk of epilepsy checked by the EEG
6)had previous neurosurgery with implants of metal
7)have pacemaker
8)attempt suicide or have the idea of suicide
9)fall into a stupor
10)have psychotic depression
11)had a history of failed response to electroconvulsive therapy
12)are depressed by organic illness or medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
Reserch Center for Innovative Oncology
National Cancer Center Hospital East
Division name
Psycho Oncology Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba JAPAN
TEL
04-7134-7013
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
Reserch Center for Innovative Oncology National Cancer Center Hospital East
Division name
Psycho Oncology Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba JAPAN
TEL
04-7134-7013
Homepage URL
asogawa@east.ncc.go.jp
Sponsor or person
Institute
Reserch Center for Innovative Oncology
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Grant from Health and Labor Sciences Reserch Grants, the third-term comprehensive control reserch for cancer
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2010 | Year | 10 | Month | 27 | Day |
Last modified on
| 2011 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003767
| 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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