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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002437
Receipt No. R000002981
Scientific Title Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Date of disclosure of the study information 2009/09/03
Last modified on 2013/09/26

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Basic information
Public title Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Acronym Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Scientific Title Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Scientific Title:Acronym Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Region
Japan

Condition
Condition major depressive disorder,
bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the reactivity in the left dorsolateral prefrontal cortex during and immediately after active and sham rTMS at low-frequency (1Hz) over the right prefrontal cortex.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes To monitor the regional cerebral blood volume changes using multichannel near-infrared spectroscopy.
Key secondary outcomes Clinical symptoms of the patients were evaluated using the 24-item Hamilton Rating Scale for Depression, and the level of social functioning of all the subjects were assessed using the Global Assessment of Functioning scores.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The low frequency repetitive transcranial magnetic stimulation to the right prefrontal cortex.
Interventions/Control_2 sham stimulation.
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
27 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria The patients with MDD and BD were diagnosed in accordance with the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th ed.
Key exclusion criteria The exclusion criteria was strictly followed the report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation by Wassermann.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MAsato Fukuda
Organization Gunma University Graduate School of Medicine
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8188
Email yaoyama@med.gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Aoyama
Organization Gunma University Graduate School of Medicine
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8188
Homepage URL
Email yaoyama@med.gunma-u.ac.jp

Sponsor
Institute Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 03 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 No longer recruiting
Date of protocol fixation
2004 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 03 Day
Last modified on
2013 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002981

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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