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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004457
Receipt No. 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

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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
Email

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
Email asogawa@east.ncc.go.jp

Sponsor
Institute Reserch Center for Innovative Oncology
National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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